FDA-Approved Non-Small Cell Lung Cancer (NSCLC) Treatments- MPR

FDA-Approved Non-Small Cell Lung Cancer (NSCLC) Treatments

FDA-APPROVED NON-SMALL CELL LUNG CANCER (NSCLC) TREATMENTS
Generic	Brand	Strength	Form	Adult Dose
Antimetabolites
gemcitabine	—	200mg, 1g, 2g	pwd for IV infusion after reconstitution	Give with cisplatin 100mg/m² administered on Day 1 after gemcitabine. 1000mg/m² on Days 1, 8, and 15 of each 28-day cycle; or 1250mg/m² on Days 1 and 8 of each 21-day cycle
metho– trexate	—	25mg/mL	soln for IV, IM, intra- arterial, or intrathecal administration after dilution	See drug monograph and manufacturer’s full labeling
	—	1g	pwd for IV, IM, intra- arterial, or intrathecal administration after dilution
	Trexall	5mg, 7.5mg, 10mg, 15mg	scored tabs
pemetrexed	Alimta	100mg, 500mg	pwd for IV infusion after reconstitution and dilution	CrCl ≥45mL/min: 500mg/m² on Day 1 of each 21-day cycle. In combination with pembrolizumab and platinum chemotherapy: treat for 4 cycles; following platinum-based therapy completion, give pemetrexed with or without pembrolizumab until disease progression or unacceptable toxicity. In combination with cisplatin: treat for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Maintenance, recurrent NSCLC: continue until disease progression or unacceptable toxicity. Supplement with oral folic acid and IM vitamin B₁₂ one week prior to 1st pemetrexed dose, during treatment, and for 21 days after last dose. Pretreat with dexamethasone for 3 consecutive days, beginning the day before each pemetrexed dose.
pemetrexed	Pemfexy	500mg/20mL	soln for IV infusion after dilution	CrCl ≥45mL/min: 500mg/m² on Day 1 of each 21-day cycle. In combination with pembrolizumab/platinum chemotherapy: give pemetrexed dose after pembrolizumab and prior to carboplatin/cisplatin; treat for 4 cycles; after platinum-based therapy completion, give pemetrexed with/without pembrolizumab until disease progression or unacceptable toxicity. In combination with cisplatin: give pemetrexed dose prior to cisplatin; treat for up to 6 cycles in the absence of disease progression or unacceptable toxicity.Maintenance, recurrent NSCLC: continue until disease progression or unacceptable toxicity. Supplement with oral folic acid one week prior to 1st pemetrexed dose, during treatment, and for 21 days after last dose. Supplement with IM vitamin B₁₂ one week prior to 1st pemetrexed dose and every 3 cycles thereafter. Pretreat with dexamethasone for 3 consecutive days, beginning the day before each pemetrexed dose.
Antimicrotubule agents
docetaxel	Taxotere	20mg/mL	soln for IV infusion after dilution	Infuse over 1hr once every 3wks. After platinum therapy failure: 75mg/m². Chemotherapy-naive: 75mg/m² followed by cisplatin (see full labeling).
paclitaxel	—	6mg/mL	soln for IV infusion after dilution	135mg/m² IV plus cisplatin every 3wks
paclitaxel [bound to albumin (human)]	Abraxane	100mg/ vial	pwd for IV infusion after reconstitution	100mg/m² on Days 1, 8, and 15 of each 21-day cycle with carboplatin
vinorelbine	—	10mg/mL	soln for IV inj after dilution	Monotherapy: 30mg/m² once weekly. Combination therapy: 25mg/m² on Days 1, 8, 15, and 22 of a 28-day cycle with cisplatin (100mg/m²) given on Day 1 of each 28-day cycle; or 30mg/m² once weekly with cisplatin (120mg/m²) given on Days 1 and 29, then every 6wks.
CTLA-4 Blocking Antibody
ipilimumab	Yervoy	5mg/mL	soln for IV infusion	Metastatic NSCLC with PD-L1: 1mg/kg every 6wks with nivolumab 3mg/kg every 2wks. Metastatic or recurrent NSCLC: 1mg/kg every 6wks with nivolumab 360mg every 3wks and histology-based platinum doublet chemotherapy every 3wks for 2 cycles. Continue with nivolumab until disease progression, unacceptable toxicity, or up to 2yrs in patients without disease progression.
tremelimumab-actl	Imjudo	20mg/mL	soln for IV infusion after dilution	Metastatic NSCLC: non-squamous or squamous: (<30kg): 1mg/kg every 3wks (with durvalumab 20mg/kg and platinum-based chemotherapy) for 4 cycles, followed by durvalumab 20mg/kg every 4wks as a single agent (with histology-based pemetrexed therapy), and a 5th dose of tremelimumab-actl 1mg/kg (with durvalumab dose 6) at week 16. (≥30kg): 75mg every 3wks (with durvalumab 1500mg and platinum-based chemotherapy) for 4 cycles, followed by durvalumab 1500mg every 4wks as a single agent (with histology-based pemetrexed therapy), and a 5th dose of tremelimumab-actl 75mg (with durvalumab dose 6) at week 16. Continue durvalumab until disease progression or intolerable toxicity. In combination with durvalumab and chemotherapy: give tremelimumab-actl first, followed by durvalumab and then platinum-based chemotherapy on the day of dosing (see full labeling). If patients receive fewer than 4 cycles of chemotherapy, give remaining tremelimumab-actl cycles (up to a total of 5) after chemotherapy phase, in combination with durvalumab, every 4wks. For patients with non-squamous disease who received pemetrexed and carboplatin/cisplatin: optional pemetrexed therapy from week 12 until disease progression or intolerable toxicity.
HER2-TARGETED ANTIBODY-DRUG CONJUGATE
fam-trastuzumab deruxtecan-nxki	Enhertu¹⁰	100mg	pwd for IV infusion after reconstitution and dilution	5.4mg/kg once every 3wks (21-day cycle) until disease progression or unacceptable toxicity
HUMAN EGFR INHIBITOR
necitumumab	Portrazza	800mg/50mL	soln for IV infusion after dilution	800mg on Days 1 and 8 of each 21-day cycle; continue until disease progression or unacceptable toxicity
Kinase Inhibitors
afatinib	Gilotrif	20mg, 30mg, 40mg	tabs	40mg once daily on empty stomach; continue until disease progression or unacceptable toxicity
alectinib	Alecensa¹	150mg	caps	600mg twice daily until disease progression or unacceptable toxicity
binimetinib	Mektovi⁴	15mg	tabs	In combination with encorafenib: 45mg twice daily (approx. 12hrs apart) until disease progression or unacceptable toxicity. Discontinue if encorafenib is permanently discontinued.
brigatinib	Alunbrig¹	30mg, 90mg, 180mg	tabs	90mg once daily for first 7 days, then increase to 180mg once daily; continue until disease progression or unacceptable toxicity.
capmatinib	Tabrecta⁶	150mg, 200mg	tabs	400mg twice daily.
ceritinib	Zykadia¹	150mg	tabs	450mg once daily with food until disease progression or unacceptable toxicity; discontinue if 150mg once daily with food not tolerated
crizotinib	Xalkori^1,5	200mg, 250mg	hard gel caps	250mg twice daily until disease progression or unacceptable toxicity
dabrafenib	Tafinlar⁴	50mg, 75mg	caps	In combination with trametinib: 150mg twice daily (approx. 12hrs apart); continue until disease recurrence or unacceptable toxicity
dacomitinib	Vizimpro²	15mg, 30mg, 45mg	tabs	45mg once daily until disease progression or unacceptable toxicity
encorafenib	Braftovi⁴	75mg	caps	In combination with binimetinib: 450mg once daily until disease progression or unacceptable toxicity
entrectinib	Rozlytrek⁵	100mg, 200mg	caps	600mg once daily until disease progression or unacceptable toxicity
erlotinib	—²	25mg, 100mg, 150mg	tabs	150mg once daily until disease progression or unacceptable toxicity
gefitinib	Iressa²	250mg	tabs	250mg once daily until disease progression or unacceptable toxicity
lorlatinib	Lorbrena¹	25mg, 100mg	tabs	100mg once daily until disease progression or unacceptable toxicity
mobocertinib	Exkivity⁹	40mg	caps	160mg once daily until disease progression or unacceptable toxicity
osimertinib	Tagrisso^2,3	40mg, 80mg	tabs	80mg once daily. Metastatic: treat until disease progression or unacceptable toxicity. Adjuvant: treat until disease recurrence, unacceptable toxicity, or for up to 3yrs.
pralsetinib	Gavreto⁷	100mg	caps	400mg once daily until disease progression or until unacceptable toxicity
selpercatinib	Retevmo⁷	40mg, 80mg	hard gel caps	<50kg: 120mg twice daily (approx. every 12hrs). ≥50kg: 160mg twice daily (approx. every 12hrs). Continue until disease progression or unacceptable toxicity.
tepotinib	Tepmetko⁶	225mg	tabs	450mg once daily until disease progression or unacceptable toxicity
trametinib	Mekinist⁴	0.5mg, 2mg	tabs	In combination with dabrafenib: 2mg once daily (approx. 24hrs apart); continue until disease recurrence or unacceptable toxicity
PD-1/PD-L1 Blocking Antibodies
atezolizumab	Tecentriq	60mg/mL	soln for IV infusion after dilution	Single agent: 840mg every 2wks, or 1200mg every 3wks, or 1680mg every 4wks. In combination with platinum-based chemotherapy: 1200mg every 3wks; after 4–6 cycles of chemotherapy completed, and if bevacizumab discontinued, give 840mg every 2wks, or 1200mg every 3wks, or 1680mg every 4wks. Adjuvant treatment of NSCLC: continue up to 1yr unless disease recurrence or unacceptable toxicity occurs. Metastatic NSCLC: continue until disease progression or unacceptable toxicity. In combination therapy: administer atezolizumab prior to chemotherapy and bevacizumab when given on the same day (see full labeling).
cemiplimab-rwlc	Libtayo	50mg/mL	soln for IV infusion after dilution	Locally advanced or metastatic NSCLC: 350mg every 3wks until disease progression or unacceptable toxicity.
durvalumab	Imfinzi	50mg/mL	soln for IV infusion after dilution	Stage III NSCLC (<30kg): 10mg/kg every 2wks; (≥30kg): 10mg/kg every 2wks or 1500mg every 4wks; continue until disease progression, unacceptable toxicity, or max 12mos. Metastatic NSCLC: non-squamous or squamous: (<30kg): 20mg/kg every 3wks (with tremelimumab-actl 1mg/kg and platinum-based chemotherapy) for 4 cycles, followed by 20mg/kg every 4wks as a single agent (with histology-based pemetrexed therapy) every 4wks, and a fifth dose of tremelimumab-actl 1mg/kg (with durvalumab dose 6) at week 16; (≥30kg): 1500mg every 3wks (with tremelimumab-actl 75mg and platinum-based chemotherapy) for 4 cycles, followed by 1500mg every 4wks as a single agent (with histology-based pemetrexed maintenance therapy) every 4wks, and a fifth dose of tremelimumab-actl 75mg (with durvalumab dose 6) at week 16. Continue durvalumab until disease progression or intolerable toxicity. In combination with tremelimumab-actl and chemotherapy: give tremelimumab-actl first, followed by durvalumab and then platinum-based chemotherapy on the day of dosing (see full labeling). If patients receive fewer than 4 cycles of chemotherapy, give remaining tremelimumab-actl cycles (up to a total of 5) after chemotherapy phase, in combination with durvalumab, every 4wks. For patients with non-squamous disease who received pemetrexed and carboplatin/cisplatin: optional pemetrexed therapy from week 12 until disease progression or intolerable toxicity.
nivolumab	Opdivo	10mg/mL	soln for IV infusion after dilution	Neoadjuvant for resectable NSCLC: 360mg every 3wks with platinum-doublet chemotherapy (on the same day) every 3wks for 3 cycles. Metastatic NSCLC with PD-L1: 360mg every 3wks (with ipilimumab 1mg/kg every 6wks), continue with ipilimumab until disease progression, unacceptable toxicity, or up to 2yrs in patients without disease progression. Metastatic or recurrent NSCLC: 360mg every 3wks (with ipilimumab 1mg/kg every 6wks) and histology-based platinum-doublet chemotherapy every 3wks (for 2 cycles only), continue with ipilimumab until disease progression, unacceptable toxicity, or up to 2yrs in patients without disease progression. Metastatic NSCLC (single-agent): 240mg every 2wks or 480mg every 4wks, until disease progression or unacceptable toxicity. Combination therapy: administer Opdivo first followed by ipilimumab, and/or platinum-doublet chemotherapy on the same day.
pembrolizumab	Keytruda	25mg/mL	soln for IV infusion after dilution	200mg every 3wks or 400mg every 6wks until disease progression, unacceptable toxicity, or up to 24mos. In combination with chemotherapy: give prior to chemotherapy when given on the same day (see full labeling). Neoadjuvant for resectable NSCLC (with chemotherapy): give for 12wks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment as a single agent after surgery for 39wks or until disease recurrence or unacceptable toxicity. Adjuvant for NSCLC (single agent): continue until disease recurrence, unacceptable toxicity, or up to 12mos.
Photosensitizing agent
porfimer	Photofrin	75mg	pwd for IV inj after reconstitution	2mg/kg then illumination with laser light 40−50hrs following injection
RAS GTPASE INHIBITOR
adagrasib	Krazati⁸	200mg	tabs	600mg twice daily until disease progression or unacceptable toxicity
sotorasib	Lumakras⁸	120mg, 320mg	tabs	960mg once daily until disease progression or unacceptable toxicity
VEGF INHIBITORS
bevaci– zumab	Avastin	100mg, 400mg	soln for IV infusion after dilution	15mg/kg every 3wks with carboplatin/paclitaxel
	Vegzelma
	Mvasi
	Zirabev
	Alymsys
ramuci– rumab	Cyramza	10mg/mL	soln for IV infusion after dilution	Exon 19 deletions or exon 21 mutations: 10mg/kg every 2wks with erlotinib. Disease progression: 10mg/kg on Day 1 of a 21-day cycle prior to docetaxel. Both: continue until disease progression or unacceptable toxicity.
NOTES
¹ For ALK-positive metastatic NSCLC only. ² For metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations only. ³ For metastatic NSCLC with EGFR T790M mutation only. ⁴ For metastatic NSCLC with BRAF V600E mutation only. ⁵ For ROS1-positive metastatic NSCLC only. ⁶ For metastatic NSCLC with mutation that leads to MET exon 14 skipping only. ⁷ For RET fusion-positive metastatic NSCLC only. ⁸ For locally advanced or metastatic NSCLC with KRAS G12C mutation only. ⁹ For locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation only. ¹⁰ For metastatic NSCLC with activating HER2 (ERBB2) mutations only. Not an inclusive list of medications, official indications, and/or dosing details. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. (Rev. 12/2023)

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