Pancreatic, thyroid, and other endocrine cancers Archives - MPR

ABRAXANE

Haymarket Media — Thu, 30 Nov 2023 19:45:31 +0000

Paclitaxel [bound to albumin (human)] 100mg/vial; pwd for IV infusion after reconstitution; solvent-free.

Adverse Events Up With Immune Checkpoint Blockade Added to Periop Cancer Therapy

Haymarket Media — Thu, 07 Dec 2023 14:00:00 +0000

HealthDay News — The addition of an immune checkpoint blockade to perioperative cancer therapy is associated with increased incidence of certain adverse events, according to a review published online November 24 in The Lancet Oncology.

Yu Fujiwara, MD, from Mount Sinai Beth Israel in New York City, and colleagues conducted a systematic review and meta-analysis to examine how adding an immune checkpoint blockade to perioperative therapy affects treatment-related adverse events. Data were included from 28 randomized controlled trials with 16,976 cancer patients.

The researchers found no significant association for addition of an immune checkpoint blockade with increased treatment-related deaths, and this finding was consistent across immune checkpoint blockade subtypes. Across 9864 patients treated with an immune checkpoint blockade, 40 fatal toxicities were identified, with pneumonitis the most common (15.0%); among 7112 patients who were not treated with an immune checkpoint blockade, 13 fatal toxicities were identified. The incidence rates of grade 3 to 4 treatment-related adverse events, adverse events leading to treatment discontinuation, and treatment-related adverse events of any grade were increased with the addition of an immune checkpoint blockade (odds ratios, 2.73, 3.67, and 2.60, respectively). Increased incidence rates of treatment-related deaths and grade 3 to 4 adverse events were seen in association with an immune checkpoint blockade vs placebo design primarily used as adjuvant therapy (odds ratios, 4.02 and 5.31, respectively), while incidence was not increased with the addition of an immune checkpoint blockade in the neoadjuvant setting.

“Our analysis points to a need for further research into risk factors and identification of appropriate biomarkers to predict both efficacy and toxicity associated with cancer immunotherapy,” Fujiwara said in a statement.

Several authors disclosed ties to the biopharmaceutical industry.

Editorial (subscription or payment may be required)

AFINITOR

Haymarket Media — Thu, 03 Mar 2022 21:17:28 +0000

Everolimus 2.5mg, 5mg, 7.5mg, 10mg; tabs.

Breakthroughs in Targeted Therapy, Immunotherapy Reduce Cancer Deaths

Erin Clancy — Mon, 18 Sep 2023 16:00:00 +0000

Breakthroughs in targeted therapy and immunotherapy are partly responsible for the recent decline in cancer deaths seen in the United States, according to the AACR Cancer Progress Report 2023.¹

The overall rate of cancer death in the US fell by 33% between 1991 and 2020, which translates to 3.8 million lives saved, according to the report. Death rates have decreased for lung cancer, colorectal cancer, prostate cancer, female breast cancer, and melanoma.

“These gains have really reflected a whole variety of different advances, but mostly this has been about efforts in basic science,” AACR President Philip D. Greenberg, MD, of Fred Hutchinson Cancer Research Center in Seattle, said during a presentation about the AACR report.

Dr Greenberg noted that initiatives such as the Human Genome Project and The Cancer Genome Atlas have enabled the creation of targeted therapies, which are “increasingly precise and decreasingly toxic.”

Immunotherapy breakthroughs have also reduced the toxicity of treatments, leading to improved quality of life for patients. “Precision oncology, personalized medicine; it’s about creating drugs and using them to very selectively target the disease and not injure the person,” Dr Greenberg summarized.

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The AACR report highlighted several targeted therapies with unique mechanisms of action that have been approved by the US Food and Drug Administration (FDA) since the early 2000s, including gefitinib in 2003, crizotinib in 2011, and sotorasib in 2021.

All of these therapies were approved to treat lung cancer, and these approvals coincided with declining lung cancer deaths. The decrease in lung cancer deaths per year grew from 0.9% between 1995 and 2005 to nearly 5% between 2014 and 2020.

The report also highlighted more recent FDA approvals. Between August 1, 2022, and July 31, 2023, the FDA approved 14 new cancer therapies and expanded the approved use of 12 therapies to encompass new cancers. The therapies include a range of cell-signaling inhibitors, antibody-drug conjugates, bispecific antibodies, and immune checkpoint inhibitors.

“A decade ago, there was 1 single immune checkpoint inhibitor,” Dr Greenberg pointed out. “Now . . . 11 checkpoint inhibitors have now been approved by the FDA up through 2023. And rather than using it to treat the single disease that it was approved for a decade ago, we now use it to treat 20 diseases.”

Two new imaging agents — pafolacianine and flotufolastat fluorine-18 —were also approved by the FDA between August 1, 2022, and July 31, 2023.

Ongoing Challenges

“Of course, despite all this progress, there’s a whole lot of work that needs to be done,” Dr Greenberg said. “There are still, even now, structural barriers for lots of people. There’s clearly disproportionate medical care being delivered to medically underserved populations. This includes, of course, racial and ethnic minorities, but it also includes the rural populations, which is not commonly appreciated, but rural populations participate very minimally in cancer trials.”

“Similarly, although precision medicine has really improved outcomes, we need ways of expanding that so that it includes more diseases,” Dr Greenberg added. “Pancreatic cancer, for example, and glioblastoma still have horrible 5-year relative survival rates, and so we need new advances.”

To address some of these challenges, the AACR has launched a new initiative known as the AACR Cancer Centers Alliance.² The initiative aims to encourage collaboration among US cancer centers and “accelerate the pace of discovery by providing an ongoing mechanism for transferring new knowledge, sharing resources . . ., and driving innovation that impacts cancer science, cancer care delivery, and science and health policy.”²

Dr Greenberg suggested that the future of cancer research is bright. “I really enthusiastically look forward to what can happen,” he said. “I think there’s no reason not to be optimistic. . . . We’re in this time of unparalleled opportunities.”

Disclosures: Dr Greenberg has relationships with Affini-T, Rapt Therapeutics, Elpiscience, Fibrogen, Immunoscape, Metagenomi, Earli, Catalio, and Nextech. No disclosures were provided in relation to the AACR Cancer Progress Report 2023. Some authors of the Cancer Discovery article declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the article for a full list of disclosures.

BSA (Boyd)

Haymarket Media — Thu, 04 Feb 2016 02:12:30 +0000

Start Over

Start Over

BSA (Mosteller)

Haymarket Media — Thu, 04 Feb 2016 02:18:34 +0000

Start Over

Start Over

CABOMETYX

Haymarket Media — Thu, 05 Oct 2023 18:55:10 +0000

Cabozantinib 20mg, 40mg, 60mg; tabs.

Cancer Patients More Likely to Die From Early Omicron Variants of SARS-CoV-2

Jen Smith — Wed, 06 Sep 2023 13:00:00 +0000

Cancer patients were more likely to die from the BA.1 and BA.2 omicron variants of SARS-CoV-2 than from wild-type SARS-CoV-2, according to research published in JAMA Oncology.^1,2

The study showed that, among US cancer patients, COVID-19 deaths were more likely during the initial omicron wave when the BA.1 and BA.2 variants were in circulation (December 2021 to February 2022) than when wild-type SARS-CoV-2 was circulating (December 2020 to February 2021).

According to data from the US Centers for Disease Control and Prevention, there were 54,692 COVID-19 deaths among patients with cancer and 1,008,510 COVID-19 deaths in the general population from March 1, 2020, through May 31, 2022.

This study included 34,350 patients with cancer and 628,156 individuals from the general population who died from COVID-19 when wild-type SARS-CoV-2 was in circulation (December 2020-February 2021), the delta variant was in circulation (July 2021-November 2021), or the BA.1 and BA.2 omicron variants were in circulation (December 2021-February 2022).

The highest number of COVID-19-related deaths among patients with cancer occurred during the 2021-2022 omicron wave. At the peak of this wave, in January 2022, there were 18% more deaths than during the peak of the wild-type period, which occurred during January 2021.

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This trend was maintained when patients were stratified by age group. The number of deaths per month among patients with cancer younger than 50 years of age was 64% higher during the 2021 to 2022 omicron wave than during the wild-type wave. The number was 62% higher among patients aged 50 to 59 years, 31% higher for those aged 60 to 69 years, and 16% higher for those aged 70 to 79 years.

When the researchers looked at individual cancer types, they found that COVID-19 deaths were more likely during the 2021-2022 omicron wave for most cancer types. The exceptions were brain cancer (mortality ratio [MR], 0.77; 95% CI, 0.65-0.90), thyroid cancer (MR, 0.76; 95% CI, 0.54-0.99), and bladder cancer (MR, 0.58; 95% CI, 0.52-0.65).

Patients with lymphoma had the greatest increase in deaths from the wild-type wave to the 2021 to 2022 omicron wave, at 38% (mortality ratio [MR], 1.38; 95% CI, 1.31-1.45).

In the general population, the highest number of COVID-19 deaths per month occurred when wild-type SARS-CoV-2 was prevalent. At the peak of the initial omicron wave in January 2022, there were 21% fewer deaths in the general US population than at the peak of the wild-type period in January 2021 (MR, 0.69; 95% CI, 0.69-0.70).

“[W]hile the general US population experienced a large reduction in COVID-19 mortality during the winter Omicron period, patients with cancer experienced the highest COVID-19 mortality during the winter Omicron period, likely due to increased SARS-CoV-2 exposure during this period combined with the reduced effectiveness of COVID-19 vaccines and increased risk of COVID-19 mortality in this population,” the researchers wrote. “With future COVID-19 waves imminent, strategies to protect those at highest risk should remain a high priority, even during future pandemic waves with less virulent SARS-CoV-2 variants.”

Disclosures: One of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

References

1. Potter AL, Vaddaraju V, Venkateswaran S, et al. Deaths due to COVID-19 in patients with cancer during different waves of the pandemic in the US. JAMA Oncol. Published online August 31, 2023. doi: 10.1001/jamaoncol.2023.3066

2. SARS-CoV-2 sequences by variant, United States, Jan 3, 2022. Our World in Data. Updated August 22, 2023. Accessed September 1, 2023.

Cancer Vaccine Safe, Induces T-Cell Responses for KRAS-Mutated Tumors

Haymarket Media — Tue, 16 Jan 2024 14:00:00 +0000

HealthDay News — For patients with immunotherapy recalcitrant KRAS-mutated tumors, the cancer vaccine ELI-002 2P is safe and induces T-cell responses, according to a study published online January 9 in Nature Medicine.

Noting that the cancer vaccine ELI-002 2P enhances lymph node delivery and immune response using Amphiphile (Amph)-modification of G12D and G12R mutant KRAS (mKRAS) peptides (Amph-Peptides-2P) together with CpG oligonucleotide adjuvant (Amph-CpG-7909), Shubham Pant, MD, MBBS, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues treated 25 patients (20 with pancreatic cancer; 5 with colorectal cancer) positive for minimal residual mKRAS disease after locoregional treatment in a phase 1 study involving fixed-dose Amph-Peptides-2P and ascending dose Amph-CpG-7909.

The researchers found no dose-limiting toxicities; the recommended phase 2 dose was 10mg Amph-CpG-7909. Overall, 21, 21, and 6 patients (84, 84, and 24%) had direct ex vivo mKRAS-specific T-cell responses, tumor biomarker responses, and biomarker clearance, respectively. Median relapse-free survival was 16.33 months. There was a correlation seen for efficacy with T-cell response; the median tumor biomarker reduction was −76.0 vs −10.2%. Median relapse-free survival was not reached compared with 4.01 months (hazard ratio, 0.14).

“Overall, this study provides important proof of concept for the safety and immunogenicity of lymph node-targeting Amphiphile vaccines and yielded promising signals of clinical activity that correlate with the magnitude of ELI-002 2P-induced T-cell response,” the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Elicio Therapeutics, which is developing ELI-002 2P and funded the study.

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Abstract/Full Text

CAPRELSA

Haymarket Media — Fri, 15 Mar 2024 14:42:24 +0000

Vandetanib 100mg, 300mg, tabs.

Chemotherapy-Induced Nausea and Vomiting Prophylaxis

Kim Daigneau — Fri, 15 May 2020 16:00:10 +0000

Chemotherapy-Induced Nausea and Vomiting Prophylaxis

CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING PROPHYLAXIS
The recommended approach for the prevention and management of chemotherapy-induced nausea and vomiting (CINV) varies by the emetic risk of the treatment regimen. Adherence to antiemetic guidelines has resulted in improved control of nausea and vomiting, and improved adherence to chemotherapy regimen. The ASCO guideline provides updated recommendations for the prevention and management of nausea and vomiting due to antineoplastic agents for cancer.
ANTIEMETIC REGIMENS
Emetic risk category^1,2	Drug regimen
High emetic risk	NK₁ receptor antagonist + 5-HT₃ receptor antagonist + dexamethasone + olanzapine
Moderate emetic risk³	5-HT₃ receptor antagonist + dexamethasone
Low emetic risk	5-HT₃ receptor antagonist OR dexamethasone
Minimal emetic risk	No routine antiemetic prophylaxis
Breakthrough / Refractory	Add to standard antiemetic regimen: olanzapine or drug of a different class or benzodiazepine or dopamine receptor antagonist or cannabinoids
ANTIEMETIC DOSING
Drug	Day 1⁴	Day 2	Day 3	Day 4
HIGH RISK
NK₁ receptor antagonist³
Aprepitant OR	125mg PO or 130mg IV	80mg PO (if oral aprepitant on Day 1)	80mg PO (if oral aprepitant on Day 1)
FosaprepitantOR	150mg IV
Rolapitant OR	180mg PO
Fosnetupitant-palonosetron⁵	235mg/0.25mg IV
Netupitant-palonosetron⁵	300mg/0.5mg PO
5-HT₃ receptor antagonist⁵
Granisetron OR	2mg PO OR 1mg or 0.01mg/kg IV OR 1 patch OR 10mg SC
Ondansetron OR	24mg PO (tabs or soluble film) OR 8mg or 0.15mg/kg IV
Palonosetron OR	0.25mg IV
Dolasetron	100mg PO
Corticosteroid
Dexamethasone⁶	12mg PO or IV⁷	8mg PO or IV^7,8,9	8mg PO or IV^7,8,9	8mg PO or IV^7,8,9
Atypical Antipsychotic
Olanzapine	10mg or 5mg PO	10mg or 5mg PO⁸	10mg or 5mg PO⁸	10mg or 5mg PO⁸
Moderate risk³
5-HT₃ receptor antagonist
Granisetron OR	2mg PO OR 1mg or 0.01mg/kg IV OR 1 patch OR 10mg SC
Ondansetron OR	8mg PO twice daily OR 8mg soluble film twice daily OR 8mg or 0.15mg/kg IV
Palonosetron OR	0.50mg PO OR 0.25mg IV
Dolasetron	100mg PO
Corticosteroid
Dexamethasone³	8mg PO or IV	8mg PO or IV¹⁰	8mg PO or IV¹⁰
LOW RISK
5-HT₃ receptor antagonist
Granisetron OR	2mg PO OR 1mg or 0.01mg/kg IV OR 1 patch OR 10mg SC
Ondansetron OR	8mg PO (tab or soluble film) OR 8mg IV
Palonosetron OR	0.25mg IV
Dolasetron	100mg PO
Corticosteroid
Dexamethasone	8mg PO or IV
NOTES
Key: 5HT₃ = 5-hydroxytryptamine-3 (serotonin); AUC = area under the curve; CINV = chemotherapy induced nausea and vomiting; IV = intravenous; NK₁ = neurokinin 1; PO = oral; SC = subcutaneous ¹ For emetic risk category of chemotherapeutic agents, see “Emetogenic Potential of Antineoplastic Agent” chart. ² Adults treated with antineoplastic combinations should receive the antiemetic regimen appropriate for the component antineoplastic agent of greatest emetic risk. ³ For adults treated with carboplatin AUC ≥4mg/mL (emetic risk is at the higher end of the moderate-emetic risk category), add NK₁ receptor antagonist for a 3-drug regimen. Dexamethasone dosing is Day 1 only: 20mg with rolapitant, and 12mg with aprepitant, fosaprepitant, or netupitant-palonosetron. ⁴ Give antiemetic regimen on the day of chemotherapy (single-day) before the dose of the antineoplastic agent. For multi-day chemotherapy, first determine the emetic risk of the agent(s) included in the regimen. Patients should receive the agent of the highest therapeutic index daily during chemotherapy and for 2 days thereafter. Granisetron transdermal patch or granisetron ext-rel inj, which deliver therapy over multiple days rather than a daily 5-HT₃ receptor antagonist, can be given. ⁵ If netupitant-palonosetron or fosnetupitant-palonosetron is used, no additional 5-HT₃ receptor antagonist is needed. ⁶ Dexamethasone dosing is for patients receiving the recommended 4-drug regimen for high-emetic risk. If NK₁ receptor antagonist was omitted, the dexamethasone dose should be adjusted to 20mg on Day 1 and 16mg on Days 2–4. ⁷ If rolapitant is used, give with dexamethasone 20mg PO or IV on Day 1, and 8mg PO or IV twice daily on Days 2–4. ⁸ For cisplatin and other high-emetic-risk single agents, dexamethasone and olanzapine should be continued on Days 2–4. For anthracycline + cyclophosphamide regimens, only continue olanzapine on Days 2–4. ⁹ If fosaprepitant is used, give with dexamethasone 8mg PO or IV on Day 2, and 8mg PO or IV twice daily on Days 3–4. ¹⁰ For moderate-emetic risk agents that are known to cause delayed nausea & vomiting (eg, cyclophosphamide, doxorubicin, oxaliplatin), may continue dexamethasone on Days 2–3.
REFERENCES
Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO Guideline Update. J Clin Oncol. 2020;38(24):2782-2797. doi:10.1200/JCO.20.01296. (Rev 5/2023)

Cisplatin Shortage Nearly Resolved; Supplies of Carboplatin, Methotrexate Increasing

Erin Clancy — Fri, 22 Sep 2023 13:05:00 +0000

The cisplatin shortage that has affected cancer centers and patients across the US is nearly resolved, according to a statement from the Biden Administration.¹

The White House reported last week that the cisplatin supply has been restored to almost 100% of pre-shortage levels.

According to the US Food and Drug Administration’s (FDA) drug shortage database, 3 companies had cisplatin available on allocation as of September 18.² Additional supplies of cisplatin are expected to be released this month and next month.

The shortage of cisplatin has occurred alongside prolonged shortages of several other cancer drugs, including methotrexate and carboplatin.³ In June, the National Comprehensive Cancer Network (NCCN) published survey results reporting that cisplatin was in short supply at 70% of included cancer centers, and carboplatin was in short supply at 93%.⁴

The FDA has worked to alleviate these shortages over the past several months.¹ In June, the FDA announced that it would work with Chinese drugmaker Qilu Pharmaceutical and Canadian pharmaceutical company Apotex to temporarily import cisplatin.⁵ According to the FDA, distribution of this product has been completed.²

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The FDA also worked with various drug manufacturers to increase production of cisplatin, carboplatin, and methotrexate.¹ According to the FDA database, several companies have methotrexate and carboplatin available now, and additional supplies of both drugs are expected this month and next month.²

“The Administration will continue to work through the FDA, the Department of Health and Human Services, and other agencies to address and prevent drug shortages and mitigate impacts to people facing a cancer diagnosis,” the White House said in its statement.¹

COMETRIQ

Haymarket Media — Wed, 06 Sep 2023 18:55:16 +0000

Cabozantinib 20mg, 80mg; caps.

Dosing Options for Levothyroxine Gel Capsule Tirosint Expanded

Steve Duffy — Wed, 05 Apr 2023 17:50:00 +0000

IBSA Pharma announced the launch of Tirosint^® (levothyroxine sodium) gel capsules in 3 new dosage strengths: 37.5mcg, 44mcg, and 62.5mcg.

Tirosint is indicated as a replacement therapy in primary (thyroid), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also approved for use as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

In addition to the 3 new dosing options, Tirosint gel capsules are available in 12 other strengths: 13mcg, 25mcg, 50mcg, 75mcg, 88mcg, 100mcg, 112mcg, 125mcg, 137mcg, 150mcg, 175mcg, and 200mcg.

“The addition of 37.5, 44 and 62.5 microgram dosages, along with the brand’s unique 13mcg dose, provides physicians and patients with much-needed flexibility in levothyroxine therapy, the standard of care for treating hypothyroidism,” said Carolyn Kong, PharmD, Chief Medical and Business Officer of IBSA Pharma Inc. “Up to this time, clinicians who wanted to prescribe oral solid formulations of levothyroxine in these doses needed to instruct caregivers and patients to split levothyroxine tablets or combine different dosage strengths. This can result in both inconvenience and significant dosing errors. Levothyroxine is a narrow therapeutic index drug with potentially deleterious clinical outcomes if administered in sub- or supratherapeutic doses.”

Tirosint-Sol, an oral solution formulation of levothyroxine sodium, is also available in similar dosage strengths.

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The Company is offering the Tirosint Copay Savings Card to assist eligible patients.

Doxorubicin HCl

Haymarket Media — Thu, 22 Jul 2021 11:30:19 +0000

Doxorubicin HCl 10mg/vial, 20mg/vial, 50mg/vial; pwd for IV inj after reconstitution; contains lactose.

Doxorubicin HCl Solution

Haymarket Media — Thu, 22 Jul 2021 11:30:23 +0000

Doxorubicin HCl 2mg/mL; soln for IV inj.

Drug-Induced Photosensitivity

Kim Daigneau — Mon, 30 Mar 2020 21:28:21 +0000

Drug-Induced Photosensitivity

DRUG-INDUCED PHOTOSENSITIVITY
Drug-induced photosensitivity: cutaneous adverse events due to exposure to a drug and either ultraviolet (UV) or visible radiation. Reactions can be classified as either photoallergic or phototoxic drug eruptions, though distinguishing between the two reactions can be difficult and usually does not affect management. The following criteria must be met to be considered as a photosensitive drug eruption: • Occurs only in the context of radiation • Drug or one of its metabolites must be present in the skin at the time of exposure to radiation • Drug and/or its metabolites must be able to absorb either visible or UV radiation
		Photoallergic drug eruption	Phototoxic drug eruption
Description		Immune-mediated mechanism of action. Response is not dose-related. Occurs after repeated exposure to the drug	More frequent and result from direct cellular damage. May be dose-dependent. Reaction can be seen with initial exposure to the drug
Incidence		Low	High
Pathophysiology		Type IV hypersensitivity reaction	Direct tissue injury
Onset		>24hrs	<24hrs
Clinical appearance		Eczematous	Exaggerated sunburn reaction with erythema, itching, and burning
Localization		May spread outside exposed areas	Only exposed areas
Pigmentary changes		Unusual	Frequent
Histology		Epidermal spongiosis, exocytosis of lymphocytes and a perivascular inflammatory infiltrate	Necrotic keratinocytes, predominantly lymphocytic and neutrophilic dermal infiltrate
PHOTOSENSITIZING DRUGS¹
Generic	Brand	Type of Reaction	Notes
ANTIMICROBIALS
Antibiotics: Beta-Lactams
cefotaxime	—	Photodistributed telangiectasia
ceftazidime	Fortaz, Tazicef	Increased susceptibility to sunburn
Antibiotics: Fluoroquinolones
ciprofloxacin	Cipro	Mild phototoxic potential. Photo-induced purpura have been reported. Persistent sequalae from phototoxicity in lung-transplant recipient on long-term immunosuppressive therapy	Typically a return to baseline 1wk after drug discontinuation
levofloxacin	—	Mild phototoxic potential. Photo-induced purpura have been reported.
moxifloxacin	Avelox	More photostable and least phototoxic
ofloxacin	—	Moderate to severe sunburn reactions
Antibiotics: Tetracyclines
doxycycline²	Doryx, Vibramycin	Mild sunburn-like reactions with erythema and burning in sun-exposed areas; photodermatitis; solar urticaria, actinic granuloma, lichenoid reactions, nail dystrophy with photo-induced onycholysis, dyschromia. Nail effects can be delayed in presentation up to 2wks following sun exposure	Severe doxycycline-induced photo-onycholysis can occur at doses as low as 20mg/day in children
minocycline	Minocin, Solodyn		Generally not considered to be significant cause
tetracycline²	—
Antibiotics: Others
dapsone	—	Phototoxic and photoallergic drug eruptions
trimethoprim	—	Photosensitivity
Antifungals
griseofulvin	—		Not a potent photosensitizer. UVA implicated in photosensitivity
itraconazole	Sporanox, Tolsura	Photosensitivity in predominantly phototoxic pattern. Erythema, edema, vesicles in sun-exposed areas	Side effects reported following 5-day course oral therapy for candidiasis
ketoconazole	—	Photodermatitis
terbinafine	—	Solar urticaria
voriconazole²	Vfend	Classic phototoxicity patterns, cheilitis, pseudoporphyria, photo-onycholysis	Second most commonly reported culprit in phototoxicity reactions. More likely in patients receiving long-term prophylactic therapy. Photosensitive eruptions occur months after drug initiation. Acute photodermatitis usually resolves upon discontinuation, however, photoaging and development of melanoma and squamous cell carcinoma in previously affected areas have been reported (esp. in children).
Antimalarials
atovaquone/ proguanil	Malarone	Blisters and skin sloughing on sun-exposed areas	Occurred within hours of exposure and resolved within days of discontinuation. Confirmed by photopatch testing.
chloroquine	—	Drug-induced photodermatoses	Also used for photoprotective effects in photosensitivity conditions (eg, polymorphous light eruption, SLE). Occur within days to weeks of starting drug and resolve after discontinuation.
hydroxychloroquine	Plaquenil	Drug-induced photodermatoses
quinine	Qualaquin	Photoallergic and phototoxic reactions. Photosensitive dermatosis (edematous, eczematous, lichenoid); photo-onycholysis	Routinely confirmed by photopatch testing
Antiretrovirals
efavirenz	Sustiva	Photosensitive eruptions (eg, polymorphous light eruption, porphyria cutanea tarda, actinic prurigo, chronic actinic dermatitis, photosensitive granuloma annulare, lichenoid photoeruption)	Photosensitive eruptions can occur in HIV patients, independent of drug
tenofovir	Vemlidy, Viread
Antituberculosis
isoniazid	—	Photosensitive dermatoses, lichenoid eruption	Confirmed by photopatch and re-challenge testing
pyrazinamide	—	Photosensitive dermatoses	Confirmed by re-challenge testing
CARDIOVASCULAR AGENTS
Antihypertensives: ACE Inhibitors
enalapril	Vasotec	Photosensitivity
quinapril	Accupril
ramipril	Altace
Antihypertensives: Angiotensin Receptor Blockers
candesartan	Atacand	Photosensitivity
irbesartan	Avapro
losartan	Cozaar
olmesartan	Benicar
telmisartan	Micardis
valsartan	Diovan
Antihypertensives: Diuretics
furosemide	Lasix	Bullous eruptions (mimicking Brunsting-Perry-type presentation of localized bullous pemphigoid)
hydrochlorothiazide²	—	Exaggerated sunburn reactions, eczematous lesions in photodistributed pattern, lichenoid eruptions, photoleukomelanoderma	Chronic eczematous photosensitivity reported lasting months to years after discontinuation
indapamide	—	Photo-onycholysis
triamterene	Dyrenium	Photosensitivity	Confirmed by photopatch testing
Antihypertensives: Calcium Channel Blockers
amlodipine	Norvasc	Photodistributed facial telangiectasia	May cross react with nifedipine
diltiazem	Cardizem	Photodistributed hyperpigmentation, photosensitive dermatitis
nifedipine	Procardia	Photodistributed facial telangiectasia, photodermatitis	May cross react with amlodipine
Antihypertensives: Others
methyldopa	—	Photosensitivity
Antiarrhythmics
amiodarone²	—	Burning/tingling sensation in sun-exposed skin followed by development of erythema and eczema, pseudoporphyria; blue-grey hyperpigmentation on sun-exposed areas	Hyperpigmentation seen in long-term, high-dose therapy. Resolves within months of discontinuation; pigmentation fades over 1-2yrs.
amiodarone²	Nexterone
dronedarone	Multaq	Photosensitivity	Significantly less phototoxic than amiodarone
quinidine	—	Eczematous dermatitis, lichenoid eruption, livedoid purpuric eruption, photoallergic reaction
Cholesterol-Lowering Agents
atorvastatin	Lipitor	Edematous erythema on sun-exposed areas
fenofibrate	Tricor	Eczematous photosensitivity, lichenoid photosensitivity
pravastatin	—	Photodistributed erythema multiforme
simvastatin	Zocor	Persistent photodistributed dermatitis, photodistributed erythema multiforme
CHEMOTHERAPY
bicalutamide	Casodex	Photosensitivity	Seen in patients with prostate cancer
capecitabine	Xeloda	Photodistributed lichenoid eruptions	Less photosensitizing than fluorouracil. Alternative treatment for those unable to tolerate fluorouracil
crizotinib	Xalkori	Phototoxicity
dacarbazine	—	Photosensitive eruptions	Can switch to temozolomide if unable to tolerate
doxorubicin	Doxil	Photosensitivity
epirubicin	Ellence	Bullous eruption
erlotinib	Tarceva	Photosensitivity
fluorouracil	—	Photosensitive eruptions, enhanced sunburn reactions, photodistributed hyperpigmentation, polymorphous light eruption-like reactions
flutamide	—	Photosensitivity	Seen in patients with prostate cancer
hydroxyurea	Droxia, Hydrea	Photodistributed dermatitis, photodistributed granulomatous rash	Seen in patients with chronic myeloid leukemia
imatinib	Gleevec	Exaggerated sunburn reactions, photo-induced dermatitis, pseudoporphyria	Seen in patients treated for chronic myelogenous leukemia. Dermatitis may resolve upon drug withdrawal and recur upon rechallenge
paclitaxel	Abraxane	Photodistributed erythema multiforme, onycholysis	Photosensitive reactions also reported for nab-paclitaxel
vandetanib	Caprelsa	Photodistributed erythematous, vesiculobullous eruption, erythema multiforme-like lesions, pigmentation in photo-exposed areas	Seen in patients treated for thyroid, lung, and hepatocellular carcinoma
vemurafenib²	Zelboraf	Phototoxicity	Common culprit
vinblastine	—	Photosensitivity
NSAIDS
celecoxib	Celebrex	Photoallergic reactions and pseudoporphyria
diclofenac	Arthrotec	Photo-onycholysis
indomethacin	Indocin	Pseudoporphyria, erythema multiforme, lichenoid eruptions
meclofenamate	—
nabumetone	—
naproxen²	Aleve	Pseudoporphyria, erythema multiforme, lichenoid eruptions	Most photosensitizing potential
oxaprozin	Daypro	Pseudoporphyria, erythema multiforme, lichenoid eruptions
piroxicam²	Feldene	Vesiculobullous, eczematous, lichenoid reactions
sulindac	—	Pseudoporphyria, erythema multiforme, lichenoid eruptions
PSYCHOTROPIC AGENTS
Antidepressants
citalopram	Celexa	Photodistributed hyperpigmentation
clomipramine	Anafranil	Photoallergy
escitalopram	Lexapro	Erythroderma on sun-exposed areas
fluoxetine	Prozac	Erythema, blisters
fluvoxamine	—	Photosensitivity
imipramine	Tofranil	Photodistributed erythema, blue-grey hyperpigmentation in photodistributed areas	Hyperpigmentation seen in long-term use
paroxetine	Paxil	Photosensitivity, photodistributed granuloma annulare
phenelzine	Nardil	Clinical photosensitivity
sertraline	Zoloft	Macular erythematous photoallergic reaction
venlafaxine	Effexor XR	Photodistributed telangiectasia
Antipsychotics
aripiprazole	Abilify	Photo-onycholysis
chlorpromazine²	—	Exaggerated sunburn reactions, lichenoid reactions, bullous eruptions; photodistributed slate-grey to violaceous hyperpigmentation	Hyperpigmentation seen in long-term, high-dose therapy. Routinely confirmed by photopatch testing.
clozapine	Clozaril	Photosensitivity, vasculitis, erythema multiforme, skin pigmentation
haloperidol	Haldol	Photosensitive dermatitis
olanzapine	Zyprexa	Photo-onycholysis
risperidone	Risperdal	Photosensitivity
thioridazine²	—	Photodistributed slate-grey to violaceous hyperpigmentation	Seen in long-term, high-dose therapy
Anxiolytics
alprazolam	Xanax	Pruritic erythema in sun-exposed areas
chlordiazepoxide	—	Photo-induced eczematous eruption
OTHERS
carbamazepine	Tegretol	Photosensitive eczematous eruptions, lichenoid eruptions	Carbamazepine-induced facial burns occured in one patient due to prolonged use of a photocopier
clopidogrel	Plavix	Lichenoid photodistributed eruption
diphenhydramine	Benadryl	Photosensitivity
eculizumab	Soliris	Photosensitivity
esomeprazole	Nexium	Photosensitive dermatitis	Resolved upon discontinuation
ethinyl estradiol	—	Photosensitive eruptions, erythematous vesicular eruptions
glyburide	Diabeta, Glynase	Eczematous photodermatitis
isotretinoin	Absorica, Amnesteem		No clinical or experimental evidence confirming isotretinoin-induced photosensitivity
leflunomide	Arava	Photosensitivity
mesalamine	Lialda, Pentasa
mesna	Mesnex
metformin	—	Erythematous and eczematous photosensitivity eruptions
pantoprazole	Protonix	Photosensitivity
pirfenidone	Esbriet	Exfoliative erythema, photoleukomelanoderma
ranitidine	—	Papulosquamous eruption on sun-exposed skin	Normalization upon discontinuation. No recurrence upon re-initiation
sitagliptin	Januvia	Prolonged photosensitive eruption
tocilizumab	Actemra	Photosensitivity
PREVENTION AND MANAGEMENT
• Caution patients of the potential reaction for drugs considered to be potent photosensitizers; monitor. • Emphasize sun avoidance and sun protection upon treatment initiation. • Discontinue offending drug once diagnosis of drug-induced photosensitivity is made. Implement secondary preventive measures (eg, sun avoidance esp. during peak daylight hours, use of sun protective clothing and sunscreens with both UVA and UVB protection) if drug discontinuation is not possible. • Administer medication in the evening if appropriate. • Use of topical or systemic corticosteroids may be helpful to treat drug-induced photosensitive eruptions in symptomatic patients.
NOTES
Key: ACE = angiotensin-converting enzyme; SLE = systemic lupus erythematosus ¹ Drugs that have been reported in medical literature to cause clinical photosensitivity are listed. Most of this literature consist of case reports and case series. Due to underreporting, it is difficult to ascertain the true incidence of photosensitivity reactions. Topically administered drugs that cause photosensitivity have been excluded, as well as drugs that cause photosensitivity as part of their desired mechanism of action. ² Considered to be potent and common causes of photosensitivity. Not an inclusive list of medications and/or official indications. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling.
REFERENCES
Adapted from Blakely KM, Drucker AM, Rosen CF. Drug-Induced Photosensitivity – An Update: Culprit Drugs, Prevention and Management. Drug Safety. 2019; 42:827-847. https://doi.org/10.1007/s40264-019-00806-5. (Rev. 11/2022)

Emetogenic Potential of Antineoplastic Agents

Haymarket Media — Tue, 10 Mar 2015 17:00:00 +0000

Emetogenic Potential of Antineoplastic Agents

EMETOGENIC POTENTIAL OF ANTINEOPLASTIC AGENTS
INTRAVENOUS/INJECTABLE AGENTS
HIGH RISK (>90% frequency)^†
AC combination: any regimen containing anthracycline + cyclophosphamide Carboplatin AUC ≥4 Carmustine (BiCNU) >250mg/m² Cisplatin Cyclophosphamide >1,500mg/m² Dacarbazine	Doxorubicin ≥60mg/m² Epirubicin (Ellence) >90mg/m² Ifosfamide (Ifex) ≥2g/m² per dose Mechlorethamine Melphalan (Evomela) ≥140mg/m² Sacituzumab govitecan-hziy (Trodelvy) Streptozocin (Zanosar)
MODERATE RISK (>30−90% frequency)^†
Aldesleukin (Proleukin) >12−15 million IU/m² Amifostine (Ethyol) >300mg/m² Amivantamab-vmjw (Rybrevant) Azacitidine (Vidaza) Bendamustine (Treanda) Busulfan (Busulfex) Carboplatin AUC <4* Carmustine (BiCNU) ≤250mg/m²* Clofarabine (Clolar) Cyclophosphamide ≤1,500mg/m² Cytarabine >200mg/m² Dactinomycin (Cosmegen)* Daunorubicin (Cerubidine)* Dual-drug liposomal cytarabine + daunorubicin (Vyxeos) Dinutuximab (Unituxin)	Doxorubicin <60mg/m²* Epirubicin (Ellence) ≤90mg/m²* Fam-trastuzumab deruxtecan-nxki (Enhertu) Idarubicin (Idamycin PFS) Ifosfamide (Ifex) <2g/m² per dose* Irinotecan (Camptosar)* Irinotecan liposomal (Onivyde) Lurbinectedin (Zepzelca) Melphalan (Evomela) <140mg/m² Methotrexate ≥250 mg/m²* Naxitamab-gqgk (Danyelza) Oxaliplatin (Eloxatin)* Romidepsin (Istodax) Temozolomide (Temodar) Trabectedin (Yondelis)*
LOW RISK (10−30% frequency)^†
Ado-trastuzumab emtansine (Kadcyla) Aldesleukin (Proleukin) ≤12 million IU/m² Amifostine (Ethyol) ≤300mg/m² Arsenic trioxide (Trisenox) Axicabtagene ciloleucel (Yescarta) Belinostat (Beleodaq) Brentuximab vedotin(Adcetris) Brexucabtagene autoleucel (Tecartus) Cabazitaxel (Jevtana) Carfilzomib (Kyprolis) Copanlisib (Aliqopa) Cytarabine (low dose) 100−200mg/m² Docetaxel (Taxotere) Doxorubicin liposomal (Doxil) Enfortumab vedotin-ejfv (Padcev) Eribulin (Halaven) Etoposide (Etopophos) Floxuridine Fluorouracil (5-FU) Gemcitabine (Gemzar) Gemtuzumab ozogamicin Idecabtagene vicleucel (Abecma) Inotuzumab ozogamicin (Besponsa) Isatuximab-irfc (Sarclisa) Ixabepilone (Ixempra)	Lisocabtagene maraleucel (Breyanzi) Loncastuximab tesirine-lpyl (Zynlonta) Methotrexate >50mg/m²−<250mg/m² Mitomycin Mitomycin pyelocalyceal solution (Jelmyto) Mitoxantrone Mogamulizumab-kpkc (Poteligeo) Moxetumomab pasudotox-tdfk (Lumoxiti) Necitumumab (Portrazza) Omacetaxine (Synribo) Paclitaxel (Taxol) Paclitaxel albumin (Abraxane) Pemetrexed (Alimta) Pentostatin Polatuzumab vedotin-piig (Polivy) Pralatrexate (Folotyn) Tafasitamab-cxix (Monjuvi) Tagraxofusp-erzs (Elzonris) Talimogene laherparepvec (Imlygic) Thiotepa (Tepadina) Tisagenlecleucel (Kymriah) Tisotumab vedotin-tftv (Tivdak) Topotecan (Hycamtin) Ziv-aflibercept (Zaltrap)
MINIMAL RISK (<10% frequency)^†
Alemtuzumab (Campath) Atezolizumab (Tecentriq) Avelumab (Bavencio) Asparaginase (Erwinaze, Rylaze) Belantamab mafodotin-blmf (Blenrep) Bevacizumab (Avastin) Bleomycin Blinatumomab (Blincyto) Bortezomib (Velcade) Cemiplimab-rwlc (Libtayo) Cetuximab (Erbitux) Cladribine Cytarabine <100mg/m² Daratumumab (Darzalex) Daratumumab + hyaluronidase-fihj (Darzalex Faspro) Decitabine (Dacogen) Denileukin diftitox (Ontak) Dexrazoxane (Totect, Zinecard) Dostarlimab-gxly (Jemperli) Durvalumab (Imfinzi) Elotuzumab (Empliciti) Fludarabine Ipilimumab (Yervoy)	Luspatercept-aamt (Reblozyl) Margetuximab-cmkb (Margenza) Methotrexate ≤50mg/m² Nelarabine (Arranon) Nivolumab (Opdivo) Obinutuzumab (Gazyva) Ofatumumab (Arzerra) Panitumumab (Vectibix) Pembrolizumab (Keytruda) Pertuzumab (Perjeta) Pertuzumab/trastuzumab + hyaluronidase-zzxf (Phesgo) Ramucirumab (Cyramza) Rituximab (Rituxan) Rituximab + hyaluronidase (Rituxan Hycela) Siltuximab (Sylvant) Temsirolimus (Torisel) Trastuzumab (Herceptin) Trastuzumab + hyaluronidase-oysk (Herceptin Hylecta) Valrubicin (Valstar) Vinblastine Vincristine Vincristine liposomal (Marqibo) Vinorelbine (Navelbine)
ORAL AGENTS
MODERATE TO HIGH RISK (≥30% frequency)^†
Altretamine (Hexalen) Avapritinib (Ayvakit) Azacitidine (Onureg) Binimetinib (Mektovi) Bosutinib (Bosulif) >400mg/day Busulfan (Myleran) ≥4mg/day Cabozantinib (Cabometyx, Cometriq) Ceritinib (Zykadia) Crizotinib (Xalkori) Cyclophosphamide ≥100mg/m²/day Dabrafenib (Tafinlar) Enasidenib (Idhifa) Encorafenib (Braftovi) Estramustine (Emcyt)	Etoposide Fedratinib (Inrebic) Imatinib (Gleevec) >400mg/day Lenvatinib (Lenvima) >12mg/day Lomustine single day (Gleostine) Midostaurin (Rydapt) Mitotane (Lysodren) Mobocertinib (Exkivity) Niraparib (Zejula) Olaparib (Lynparza) Procarbazine (Matulane) Rucaparib (Rubraca) Selinexor (Xpovio) Temozolomide (Temodar) >75mg/m²/day
MINIMAL TO LOW RISK (<30% frequency)^†
Abemaciclib (Verzenio) Acalabrutinib (Calquence) Afatinib (Gilotrif) Alectinib (Alecensa) Alpelisib (Piqray), Vijoice) Asciminib (Scemblix) Axitinib (Inlyta) Belzutifan (Welireg) Bexarotene (Targretin) Brigatinib (Alunbrig) Bosutinib (Bosulif) ≤400mg/day Busulfan (Myleran) <4mg/day Capecitabine (Xeloda) Capmatinib (Tabrecta) Chlorambucil (Leukeran) Cobimetinib (Cotellic) Cyclophosphamide <100mg/m²/day Dacomitinib (Vizimpro) Dasatinib (Sprycel) Decitabine/cedazuridine (Inqovi) Duvelisib (Copiktra) Entrectinib (Rozlytrek) Erdafitinib (Balversa) Erlotinib (Tarceva) Everolimus (Afinitor) Fludarabine Gefitinib (Iressa) Gilteritinib (Xospata) Glasdegib (Daurismo) Hydroxyurea (Hydrea) Ibrutinib (Imbruvica) Idelalisib (Zydelig) Imatinib (Gleevec) ≤400mg/day Infigratinib (Truseltiq) Ivosidenib (Tibsovo) Ixazomib (Ninlaro) Lapatinib (Tykerb) Larotrectinib (Vitrakvi) Lenalidomide (Revlimid) Lenvatinib (Lenvima) ≤12mg/day Lorlatinib (Lorbrena)	Melphalan (Alkeran) Mercaptopurine Methotrexate Neratinib (Nerlynx) Nilotinib (Tasigna) Osimertinib (Tagrisso) Palbociclib (Ibrance) Pazopanib (Votrient) Pemigatinib (Pemazyre) Pexidartinib (Turalio) Pomalidomide (Pomalyst) Ponatinib (Iclusig) Pralsetinib (Gavreto) Regorafenib (Stivarga) Ribociclib (Kisqali) Ripretinib (Qinlock) Ruxolitinib (Jakafi) Selpercatinib (Retevmo) Sonidegib (Odomzo) Sorafenib (Nexavar) Sotorasib (Lumakras) Sunitinib (Sutent) Talazoparib tosylate (Talzenna) Tazemetostat (Tazverik) Temozolomide (Temodar) ≤75mg/m²/day Tepotinib (Tepmetko) Thalidomide (Thalomid) Thioguanine Tivozanib (Fotivda) Topotecan (Hycamtin) Trametinib (Mekinist) Tretinoin Trifluridine/tipiracil (Lonsurf) Tucatinib (Tukysa) Vandetanib (Caprelsa) Vemurafenib (Zelboraf) Venetoclax (Venclexta) Vismodegib (Erivedge) Vorinostat (Zolinza) Zanubrutinib (Brukinsa)
NOTES
^† Frequency of emesis in the absence of effective antiemetic prophylaxis. ^* May be highly emetogenic in certain patients.
REFERENCES
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Antiemesis. Version 2.2022—March 23, 2022. https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed May 23, 2022. (Rev. 5/2022)

EMETOGENIC POTENTIAL OF ANTINEOPLASTIC AGENTS

INTRAVENOUS/INJECTABLE AGENTS

HIGH RISK (>90% frequency)^†

AC combination: any regimen containing anthracycline + cyclophosphamide

Carboplatin AUC ≥4

Carmustine (BiCNU) >250mg/m²

Cisplatin

Cyclophosphamide >1,500mg/m²

Dacarbazine

Doxorubicin ≥60mg/m²

Epirubicin (Ellence) >90mg/m²

Ifosfamide (Ifex) ≥2g/m² per dose

Mechlorethamine

Melphalan (Evomela) ≥140mg/m²

Sacituzumab govitecan-hziy (Trodelvy)

Streptozocin (Zanosar)

MODERATE RISK (>30−90% frequency)^†

Aldesleukin (Proleukin) >12−15 million IU/m²

Amifostine (Ethyol) >300mg/m²

Amivantamab-vmjw (Rybrevant)

Azacitidine (Vidaza)

Bendamustine (Treanda)

Busulfan (Busulfex)

Carboplatin AUC <4*

Carmustine (BiCNU) ≤250mg/m²*

Clofarabine (Clolar)

Cyclophosphamide ≤1,500mg/m²

Cytarabine >200mg/m²

Dactinomycin (Cosmegen)*

Daunorubicin (Cerubidine)*

Dual-drug liposomal cytarabine + daunorubicin (Vyxeos)

Dinutuximab (Unituxin)

Doxorubicin <60mg/m²*

Epirubicin (Ellence) ≤90mg/m²*

Fam-trastuzumab deruxtecan-nxki (Enhertu)

Idarubicin (Idamycin PFS)

Ifosfamide (Ifex) <2g/m² per dose*

Irinotecan (Camptosar)*

Irinotecan liposomal (Onivyde)

Lurbinectedin (Zepzelca)

Melphalan (Evomela) <140mg/m²

Methotrexate ≥250 mg/m²*

Naxitamab-gqgk (Danyelza)

Oxaliplatin (Eloxatin)*

Romidepsin (Istodax)

Temozolomide (Temodar)

Trabectedin (Yondelis)*

LOW RISK (10−30% frequency)^†

Ado-trastuzumab emtansine (Kadcyla)

Aldesleukin (Proleukin) ≤12 million IU/m²

Amifostine (Ethyol) ≤300mg/m²

Arsenic trioxide (Trisenox)

Axicabtagene ciloleucel (Yescarta)

Belinostat (Beleodaq)

Brentuximab vedotin(Adcetris)

Brexucabtagene autoleucel (Tecartus)

Cabazitaxel (Jevtana)

Carfilzomib (Kyprolis)

Copanlisib (Aliqopa)

Cytarabine (low dose) 100−200mg/m²

Docetaxel (Taxotere)

Doxorubicin liposomal (Doxil)

Enfortumab vedotin-ejfv (Padcev)

Eribulin (Halaven)

Etoposide (Etopophos)

Floxuridine

Fluorouracil (5-FU)

Gemcitabine (Gemzar)

Gemtuzumab ozogamicin

Idecabtagene vicleucel (Abecma)

Inotuzumab ozogamicin (Besponsa)

Isatuximab-irfc (Sarclisa)

Ixabepilone (Ixempra)

Lisocabtagene maraleucel (Breyanzi)

Loncastuximab tesirine-lpyl (Zynlonta)

Methotrexate >50mg/m²−<250mg/m²

Mitomycin

Mitomycin pyelocalyceal solution (Jelmyto)

Mitoxantrone

Mogamulizumab-kpkc (Poteligeo)

Moxetumomab pasudotox-tdfk (Lumoxiti)

Necitumumab (Portrazza)

Omacetaxine (Synribo)

Paclitaxel (Taxol)

Paclitaxel albumin (Abraxane)

Pemetrexed (Alimta)

Pentostatin

Polatuzumab vedotin-piig (Polivy)

Pralatrexate (Folotyn)

Tafasitamab-cxix (Monjuvi)

Tagraxofusp-erzs (Elzonris)

Talimogene laherparepvec (Imlygic)

Thiotepa (Tepadina)

Tisagenlecleucel (Kymriah)

Tisotumab vedotin-tftv (Tivdak)

Topotecan (Hycamtin)

Ziv-aflibercept (Zaltrap)

MINIMAL RISK (<10% frequency)^†

Alemtuzumab (Campath)

Atezolizumab (Tecentriq)

Avelumab (Bavencio)

Asparaginase (Erwinaze, Rylaze)

Belantamab mafodotin-blmf (Blenrep)

Bevacizumab (Avastin)

Bleomycin

Blinatumomab (Blincyto)

Bortezomib (Velcade)

Cemiplimab-rwlc (Libtayo)

Cetuximab (Erbitux)

Cladribine

Cytarabine <100mg/m²

Daratumumab (Darzalex)

Daratumumab + hyaluronidase-fihj (Darzalex Faspro)

Decitabine (Dacogen)

Denileukin diftitox (Ontak)

Dexrazoxane (Totect, Zinecard)

Dostarlimab-gxly (Jemperli)

Durvalumab (Imfinzi)

Elotuzumab (Empliciti)

Fludarabine

Ipilimumab (Yervoy)

Luspatercept-aamt (Reblozyl)

Margetuximab-cmkb (Margenza)

Methotrexate ≤50mg/m²

Nelarabine (Arranon)

Nivolumab (Opdivo)

Obinutuzumab (Gazyva)

Ofatumumab (Arzerra)

Panitumumab (Vectibix)

Pembrolizumab (Keytruda)

Pertuzumab (Perjeta)

Pertuzumab/trastuzumab + hyaluronidase-zzxf (Phesgo)

Ramucirumab (Cyramza)

Rituximab (Rituxan)

Rituximab + hyaluronidase (Rituxan Hycela)

Siltuximab (Sylvant)

Temsirolimus (Torisel)

Trastuzumab (Herceptin)

Trastuzumab + hyaluronidase-oysk (Herceptin Hylecta)

Valrubicin (Valstar)

Vinblastine

Vincristine

Vincristine liposomal (Marqibo)

Vinorelbine (Navelbine)

ORAL AGENTS

MODERATE TO HIGH RISK (≥30% frequency)^†

Altretamine (Hexalen)

Avapritinib (Ayvakit)

Azacitidine (Onureg)

Binimetinib (Mektovi)

Bosutinib (Bosulif) >400mg/day

Busulfan (Myleran) ≥4mg/day

Cabozantinib (Cabometyx, Cometriq)

Ceritinib (Zykadia)

Crizotinib (Xalkori)

Cyclophosphamide ≥100mg/m²/day

Dabrafenib (Tafinlar)

Enasidenib (Idhifa)

Encorafenib (Braftovi)

Estramustine (Emcyt)

Etoposide

Fedratinib (Inrebic)

Imatinib (Gleevec) >400mg/day

Lenvatinib (Lenvima) >12mg/day

Lomustine single day (Gleostine)

Midostaurin (Rydapt)

Mitotane (Lysodren)

Mobocertinib (Exkivity)

Niraparib (Zejula)

Olaparib (Lynparza)

Procarbazine (Matulane)

Rucaparib (Rubraca)

Selinexor (Xpovio)

Temozolomide (Temodar) >75mg/m²/day

MINIMAL TO LOW RISK (<30% frequency)^†

Abemaciclib (Verzenio)

Acalabrutinib (Calquence)

Afatinib (Gilotrif)

Alectinib (Alecensa)

Alpelisib (Piqray), Vijoice)

Asciminib (Scemblix)

Axitinib (Inlyta)

Belzutifan (Welireg)

Bexarotene (Targretin)

Brigatinib (Alunbrig)

Bosutinib (Bosulif) ≤400mg/day

Busulfan (Myleran) <4mg/day

Capecitabine (Xeloda)

Capmatinib (Tabrecta)

Chlorambucil (Leukeran)

Cobimetinib (Cotellic)

Cyclophosphamide <100mg/m²/day

Dacomitinib (Vizimpro)

Dasatinib (Sprycel)

Decitabine/cedazuridine (Inqovi)

Duvelisib (Copiktra)

Entrectinib (Rozlytrek)

Erdafitinib (Balversa)

Erlotinib (Tarceva)

Everolimus (Afinitor)

Fludarabine

Gefitinib (Iressa)

Gilteritinib (Xospata)

Glasdegib (Daurismo)

Hydroxyurea (Hydrea)

Ibrutinib (Imbruvica)

Idelalisib (Zydelig)

Imatinib (Gleevec) ≤400mg/day

Infigratinib (Truseltiq)

Ivosidenib (Tibsovo)

Ixazomib (Ninlaro)

Lapatinib (Tykerb)

Larotrectinib (Vitrakvi)

Lenalidomide (Revlimid)

Lenvatinib (Lenvima) ≤12mg/day

Lorlatinib (Lorbrena)

Melphalan (Alkeran)

Mercaptopurine

Methotrexate

Neratinib (Nerlynx)

Nilotinib (Tasigna)

Osimertinib (Tagrisso)

Palbociclib (Ibrance)

Pazopanib (Votrient)

Pemigatinib (Pemazyre)

Pexidartinib (Turalio)

Pomalidomide (Pomalyst)

Ponatinib (Iclusig)

Pralsetinib (Gavreto)

Regorafenib (Stivarga)

Ribociclib (Kisqali)

Ripretinib (Qinlock)

Ruxolitinib (Jakafi)

Selpercatinib (Retevmo)

Sonidegib (Odomzo)

Sorafenib (Nexavar)

Sotorasib (Lumakras)

Sunitinib (Sutent)

Talazoparib tosylate (Talzenna)

Tazemetostat (Tazverik)

Temozolomide (Temodar) ≤75mg/m²/day

Tepotinib (Tepmetko)

Thalidomide (Thalomid)

Thioguanine

Tivozanib (Fotivda)

Topotecan (Hycamtin)

Trametinib (Mekinist)

Tretinoin

Trifluridine/tipiracil (Lonsurf)

Tucatinib (Tukysa)

Vandetanib (Caprelsa)

Vemurafenib (Zelboraf)

Venetoclax (Venclexta)

Vismodegib (Erivedge)

Vorinostat (Zolinza)

Zanubrutinib (Brukinsa)

NOTES

^† Frequency of emesis in the absence of effective antiemetic prophylaxis. ^* May be highly emetogenic in certain patients.

REFERENCES

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Antiemesis. Version 2.2022—March 23, 2022. https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed May 23, 2022.

(Rev. 5/2022)

Erlotinib

Haymarket Media — Tue, 21 Nov 2023 17:54:46 +0000

Erlotinib (as HCl) 25mg, 100mg, 150mg; tabs.

FDA Drug Approval Decisions Expected in February 2024

Steve Duffy — Fri, 12 Jan 2024 17:25:00 +0000

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.

Irinotecan Liposome Injection (Onivyde^®) Regimen for Pancreatic Ductal Adenocarcinoma

PDUFA date: February 13, 2024

The FDA is reviewing the supplemental NDA (sNDA) for irinotecan liposome injection (Onivyde) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) for the first-line treatment for metastatic pancreatic ductal adenocarcinoma. Irinotecan liposome injection is a topoisomerase 1 inhibitor encapsulated in a lipid bilayer vesicle or liposome.The sNDA is supported by data from the phase 3 NAPOLI 3 trial (ClinicalTrials.gov Identifier: NCT04083235). Results showed a statistically significant improvement in overall survival and progression free survival in patients treated with NALIRIFOX compared with those who received nab-paclitaxel and gemcitabine.

Cefepime-Taniborbactam for Complicated Urinary Tract Infections, Including Pyelonephritis

PDUFA date: February 22, 2024

Cefepime-taniborbactam is an investigational intravenous beta-lactam/beta-lactamase inhibitor antibiotic. The combination has demonstrated in vitro activity against clinically significant gram-negative bacteria, including carbapenem-resistant Enterobacterales, multidrug-resistant Pseudomonas aeruginosa and extended spectrum beta-lactamase-producing Enterobacterales. The NDA is supported by data from the phase 3 CERTAIN-1 study (ClinicalTrials.gov Identifier: NCT03840148), which compared the efficacy and safety of cefepime-taniborbactam to meropenem in 661 adults with cUTI, including acute pyelonephritis. Findings showed treatment with cefepime-taniborbactam was noninferior to meropenem at the test of cure visit.

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Lifileucel for the Treatment of Advanced Melanoma

PDUFA date: February 24, 2024

Lifileucel is a one-time autologous adoptive cell transfer therapy that utilizes a tumor infiltrating lymphocyte manufacturing process. The BLA is supported by data from the C-144-01 study (ClinicalTrials.gov Identifier: NCT02360579), which evaluated lifileucel in adults with advanced melanoma. The efficacy analysis included 153 patients, all of whom had progressed on or after immune checkpoint inhibitor therapy and targeted BRAF/MEK inhibitor therapy where appropriate. Findings showed lifileucel was associated with clinically meaningful and durable responses.

Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

PDUFA date: February 26, 2024

Roluperidone is an investigational 5-HT2_A, sigma₂ and α _1A-adrenergic receptor antagonist. The NDA submission included data from phase 3 MIN-101 study (ClinicalTrials.gov Identifier: NCT03397134), which evaluated the efficacy and safety of roluperidone in 513 adult patients with moderate to severe negative symptoms of schizophrenia. Findings showed an improvement in negative symptoms (as measured by the Positive and Negative Syndrome Scale PANSS Marder Negative Symptoms Factor Score) in patients receiving roluperidone 64mg compared with placebo.

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FDA to Review Novel Regimen for Treating Metastatic Pancreatic Ductal Adenocarcinoma

Steve Duffy — Wed, 14 Jun 2023 21:00:00 +0000

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for irinotecan liposome injection (Onivyde^®) plus 5 fluorouracil/leucovorin and oxaliplatin for the first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC).

The sNDA is supported by data from the open-label, randomized, multicenter phase 3 NAPOLI 3 trial (ClinicalTrials.gov Identifier: NCT04083235) that evaluated the efficacy and safety of liposomal irinotecan in 770 patients who have not previously received chemotherapy for mPDAC. Patients were randomly assigned 1:1 to receive either irinotecan liposome plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) twice a month (days 1 and 15 of 28-day cycle) vs an injection of nab-paclitaxel and gemcitabine administered 3 times a month (days 1, 8, 15 of a 28-day cycle).

Results showed that patients in the NALIRIFOX arm achieved a statistically significant improvement in median overall survival (OS; primary endpoint) of 11.1 months compared with 9.2 months for those in the nab-paclitaxel and gemcitabine arm (hazard ratio [HR], 0.83; 95% CI, 0.70-0.99; P =.04). At 12 and 18 months, the OS rates were 45.6% and 26.2%, respectively, for the NALIRIFOX arm compared with 39.5% and 19.3%, respectively, for the nab-paclitaxel and gemcitabine arm.

Additionally, patients in the NALIRIFOX arm achieved a statistically significant improvement in median progression-free survival (secondary endpoint) of 7.4 months compared with 5.6 months for those in the nab-paclitaxel and gemcitabine arm (HR, 0.69; 95% CI, 0.58-0.83; P =.0001). The NALIRIFOX arm had an objective response rate of 41.8% compared with 36.2% in the nab-paclitaxel and gemcitabine arm.

The safety profile of NALIRIFOX was consistent with the known profiles of the individual components. The most common Grade 3/4 treatment-emergent adverse event with more than 10% frequency in patients receiving NALIRIFOX vs nab-paclitaxel and gemcitabine included diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), hypokalemia (15.1% vs 4.0%), anemia (10.5% vs 17.4%), and neutropenia (14.1% vs 24.5%).

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A Prescription Drug User Fee Act target date of February 13, 2024 has been set for this application.

“The FDA’s decision to accept the sNDA for this Onivyde-based regimen in treatment-naïve patients with metastatic disease represents an important milestone in the potential treatment of this complex form of cancer,” said Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen. “We’re committed to developing therapies which have the potential to make a meaningful difference to the lives of people living with cancer and look forward to working with FDA as they review this application.”

Fluorouracil

Haymarket Media — Fri, 22 Mar 2024 18:16:04 +0000

Fluorouracil 50mg/mL; soln for IV inj or infusion.

GAVRETO

Haymarket Media — Thu, 17 Aug 2023 19:43:42 +0000

Pralsetinib 100mg; caps.

Gavreto Indication for RET-Mutant Medullary Thyroid Cancer Withdrawn

Steve Duffy — Mon, 10 Jul 2023 20:40:00 +0000

Genentech, in partnership with Blueprint Medicines, has voluntarily withdrawn the US indication of Gavreto^® (pralsetinib) for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy.

Gavreto was granted accelerated approval for this indication in December 2020 based on data from the phase 1/2 ARROW study (ClinicalTrials.gov Identifier: NCT03037385). A conversion to full approval was contingent upon demonstration of clinical benefit in the phase 3 AcceleRET MTC study (ClinicalTrials.gov Identifier: NCT04760288).

Following a discussion with the Food and Drug Administration (FDA), it was decided that the indication would be withdrawn as the confirmatory trial “could not be activated to fulfill the postmarketing requirement,” according to the Companies.

This action does not affect the other approved indications for Gavreto. Patients who are being treated with Gavreto for RET-mutant MTC should be informed of the withdrawal and be provided with other care options.

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Gemcitabine

Haymarket Media — Wed, 28 Jul 2021 21:44:47 +0000

Gemcitabine HCl 200mg, 1g, 2g; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free; contains mannitol.