FDA-Approved Colorectal Cancer Treatments- MPR

FDA-Approved Colorectal Cancer Treatments

FDA-APPROVED COLORECTAL CANCER TREATMENTS
Generic	Brand	Strength	Form	Adult Dose
Alkylating agents
oxaliplatin	Eloxatin	5mg/mL	soln for IV infusion after dilution	Day 1: 85mg/m² + leucovorin, followed by 5−FU. Day 2: Leucovorin followed by 5−FU. Give by IV infusion every 2wks for a total of 6mos (12 cycles) for adjuvant use or until disease progression or unacceptable toxicity for advanced disease.
Antimetabolites
capecitabine	Xeloda	150mg, 500mg	tabs	1250mg/m² twice daily for 2wks on and 1wk off, for a total of 8 cycles.
fluorouracil	—	50mg/mL	soln for IV inj	12mg/kg once daily for 4 successive days; max 800mg/day. If no toxicity, then 6mg/kg on days 6, 8, 10, 12; stop after day 12. Discontinue if toxicity occurs.
ANTIMETABOLITES + PHOSPHORYLASE INHIBITORS
trifluridine/ tipiracil	Lonsurf	15mg/6.14mg, 20mg/8.19mg	tabs	Days 1−5, 8−12: 35mg/m² twice daily; continue every 28-day cycle until disease progression or unacceptable toxicity; max 80mg/dose (based on trifluridine component).
CTLA-4 BLOCKING ANTIBODY
ipilimumab	Yervoy³	5mg/mL	soln for IV infusion	In combination with nivolumab: 1mg/kg as an IV infusion over 30mins (given after nivolumab 3mg/kg on the same day) every 3wks for 4 doses. After completing 4 doses of the combination, give nivolumab as a single agent until disease progression or unacceptable toxicity.
EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) INHIBITORS
cetuximab	Erbitux²	100mg, 200mg	soln for IV infusion	Give by IV infusion; max rate: 10mg/min. Single agent or in combination with irinotecan or FOLFIRI: Weekly regimen (initial dose): 400mg/m² once over 2hrs; (subsequent doses): 250mg/m² once weekly over 1hr. Biweekly regimen (initial and subsequent doses): 500mg/m² every 2wks over 2hrs. Complete administration 1hr prior to irinotecan or FOLFIRI. In combination with encorafenib (initial dose): 400mg/m² once over 2hrs; (subsequent doses): 250mg/m² once weekly over 1hr. All: continue until disease progression or unacceptable toxicity.
panitu– mumab	Vectibix⁴	20mg/mL	soln for IV infusion after dilution	6mg/kg as IV inf over 60min once every 14 days. Doses >1000mg: infuse over 90min.
Folic acid derivative
leucovorin	—	100mg, 350mg	lyophilized pwd for IV or IM inj reconsti– tution	200mg/m² by slow IV inj over a minimum of 3min followed by 5−fluorouracil (370mg/m²); or 20mg/m² IV followed by 5 fluorouracil (425mg/m²); both regimens: daily for 5 days, may be repeated at 4‑wk intervals for 2 courses and then repeated at 4−5‑wk intervals.
levoleu– covorin	Fusilev	50mg/vial	lyophilized pwd for IV inj after reconsti– tution	100mg/m² by slow IV inj over a minimum of 3min, followed by 5‑FU at 370mg/m² by IV inj; or 10mg/m² by IV inj followed by 5‑FU at 425mg/m² by IV inj. Treat daily for 5 days; may repeat 5-day course at 4wk intervals for 2 courses, then at 4–5wk intervals provided that patient recovered completely from toxic effects from prior treatment course. Administer 5-FU separately to avoid precipitate formation.
levoleu– covorin	Khapzory	175mg/ vial, 300mg/ vial	lyophilized pwd for IV inj after reconsti– tution and dilution
Fusion Protein
ziv-aflibercept	Zaltrap	25mg/mL	soln for IV infusion after dilution	4mg/kg as an IV infusion over 1hr every 2wks; continue until disease progression or unacceptable toxicity
KINASE INHIBITORS
encorafenib	Braftovi¹	75mg	caps	In combination with cetuximab: 300mg once daily until disease progression or unacceptable toxicity. Discontinue Braftovi if cetuximab is discontinued.
regorafenib	Stivarga	40mg	tabs	160mg once daily for the first 21 days of each 28-day cycle; continue until disease progression or unacceptable toxicity.
tucatinib	Tukysa⁵	50mg, 150mg	tabs	In combination with trastuzumab: 300mg twice daily, approx. 12hrs apart, until disease progression or unacceptable toxicity. Concomitant strong CYP2C8 inhibitors (if unavoidable): 100mg twice daily. Severe hepatic impairment: 200mg twice daily.
PD-1/PD-L1 BLOCKING ANTIBODIES
nivolumab	Opdivo³	10mg/mL	soln for IV infusion after dilution	Give as IV infusion over 30mins. Continue until disease progression or unacceptable toxicity. Single-agent (≥40kg): 240mg every 2wks or 480mg every 4wks; (<40kg): 3mg/kg every 2wks. In combination with ipilimumab: 3mg/kg (followed by ipilimumab on the same day) every 3wks for 4 doses, then followed by 240mg every 2wks or 480mg every 4wks (≥40kg) or 3mg/kg every 2wks (<40kg) as single agent.
pembroli– zumab	Keytruda³	25mg/mL	soln for IV infusion after dilution	Give as IV infusion over 30mins. 200mg every 3wks or 400mg every 6wks until disease progression, unacceptable toxicity, or up to 24mos in patients without disease progression.
Topoisomerase inhibitors
irinotecan	Camptosar	20mg/mL	soln for IV infusion after dilution	Combination therapy (with 5‑FU and leucovorin): 125mg/m² on days 1, 8, 15, 22; or, 180mg/m² on days 1, 15, 29; both: give every 6wks. Monotherapy: 125mg/m² on days 1, 8, 15, 22, then 2‑week rest; or, 350mg/m² once every 3wks.
VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF) INHIBITORS
bevacizumab	Avastin	100mg, 400mg	soln for IV infusion after dilution	5mg/kg (with bolus−IFL) or 10mg/kg (with FOLFOX−4) once every 2wks until disease progression; 5mg/kg every 2wks or 7.5mg/kg every 3wks (when used with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based therapy). 1st infusion over 90min, 2nd infusion over 60min, subsequent infusion over 30min.
bevacizumab-adcd	Vegzelma
bevacizumab-awwb	Mvasi
bevacizumab-bvzr	Zirabev
bevacizumab-maly	Alymsys
ramucirumab	Cyramza	10mg/mL	soln for IV infusion after dilution	In combination with FOLFIRI: 8mg/kg as an IV infusion over 60mins every 2wks until disease progression or unacceptable toxicity. Administer prior to FOLFIRI.
NOTES
¹ For BRAF V600E mutation colorectal cancer only. ² For wild-type K-RAS, EGFR-expressing colorectal cancer only. ³ For microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. ⁴ For wild-type RAS colorectal cancer only. ⁵ For wild-type RAS HER2-positive unresectable or metastatic colorectal cancer 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. 6/2023)

Want to read more?