FDA-Approved Melanoma Treatments

FDA-APPROVED MELANOMA TREATMENTS
Generic	Brand	Strength	Form	Adult Dose
ALKYLATING AGENT
dacarbazine	—	200mg/vial	pwd for IV infusion after reconstitution and dilution	Malignant melanoma: 2–4.5mg/kg/day IV for 10 days, may repeat every 4wks; or 250mg/m² daily for 5 days, may repeat every 3wks.
CTLA-4 BLOCKING ANTIBODY
ipilimumab	Yervoy	5mg/mL	soln for IV infusion	Infuse over 90mins. Single agent: 3mg/kg every 3wks for max 4 doses. In combination with nivolumab: 3mg/kg every 3wks (given after nivolumab on the same day) for max 4 doses or until unacceptable toxicity, whichever occurs earlier; after completing 4 doses of the combination, give nivolumab (as a single agent) until disease progression or unacceptable toxicity. Adjuvant (cutaneous): 10mg/kg every 3wks for max 4 doses, followed by 10mg/kg every 12wks for up to 3yrs; may omit doses if toxicity occurs.
INTERFERONS
interferon alfa-2b¹	Intron A	10 million IU, 18 million IU, 50 million IU; per vial	pwd for inj after reconstitution and dilution	Malignant melanoma: Induction (use pwd form only): 20million IU/m² IV over 20mins, 5 consecutive days per week, for 4wks. Maintenance: 10 million IU/m² SC 3 times per week for 48wks.
interferon alfa-2b¹	Intron A	10 million IU, 18 million IU, 25 million IU; per vial	soln for SC inj
peginterferon alfa-2b	Sylatron	296mcg, 444mcg, 888mcg	lyophilized pwd for SC inj after reconstitution	Adjuvant: 6mcg/kg/week SC for 8 doses, followed by 3mcg/kg/week for up to 5yrs. Renal impairment (moderate): initially 4.5mcg/kg/week for 8 doses, followed by 2.25mcg/kg/week for up to 5yrs; (severe or ESRD on dialysis): initially 3mcg/kg/week for 8 doses, followed by 1.5mcg/kg/week for up to 5yrs.
INTERLEUKIN-2
aldesleukin¹	Proleukin	22 million IU/ vial	pwd for IV infusion after reconstitution and dilution	600,000 IU/kg (0.037mg/kg) every 8hrs by IV infusion over 15mins for max 14 doses, followed by 9 days rest, then repeat for another 14 doses (max 28 doses/course), as tolerated. Retreatment: see full labeling.
KINASE INHIBITORS
binimetinib	Mektovi²	15mg	tabs	45mg twice daily (approx. 12hrs apart) with encorafenib until disease progression or unacceptable toxicity. Moderate or severe hepatic impairment: 30mg twice daily. Discontinue if encorafenib is permanently discontinued.
cobimetinib	Cotellic²	20mg	tabs	60mg once daily for first 21 days of each 28-day cycle, in combination with vemurafenib, until disease progression or unacceptable toxicity.
dabrafenib	Tafinlar²	50mg, 75mg	caps	Take at least 1hr before or 2hrs after a meal. Monotherapy or in combination with trametinib: 150mg twice daily (approx. 12hrs apart) until disease progression or unacceptable toxicity. Adjuvant treatment with trametinib: 150mg twice daily (approx. 12hrs apart) until disease recurrence or unacceptable toxicity for up to 1yr.
encorafenib	Braftovi²	75mg	caps	450mg once daily with binimetinib until disease progression or unacceptable toxicity.
trametinib	Mekinist²	0.5mg, 2mg	tabs	Take at same time each day, at least 1hr before or 2hrs after a meal. Monotherapy or in combination with dabrafenib: 2mg once daily (approx. 24hrs apart) until disease progression or unacceptable toxicity. Adjuvant treatment with dabrafenib: 2mg once daily (approx. 24hrs apart) until disease recurrence or unacceptable toxicity for up to 1yr.
vemurafenib	Zelboraf²	240mg	tabs	960mg every 12hrs until disease progression or unacceptable toxicity.
ONCOLYTIC VIRAL THERAPY
talimogene laherparepvec	Imlygic	106 (1 million) PFU/mL, 108 (100 million) PFU/mL	susp for intralesional inj	Inject intralesionally into cutaneous, subcutaneous, and/or nodal lesions. Total inj volume per treatment visit: max 4mL for all injected lesions combined. Initial dose: up to 4mL of 10⁶ (1 million) PFU/mL. 2nd dose: up to 4mL of 10⁸ (100 million) PFU/mL given 3wks later. All subsequent doses (including reinitiation): up to 4mL of 10⁸ (100 million) PFU/mL given 2wks apart. Continue for ≥6mos unless other treatment required or until no lesions to treat; reinitiate if new lesions appear after a complete response.
PD-1/PD-L1 BLOCKING ANTIBODIES
atezolizumab	Tecentriq³	60mg/mL	soln for IV infusion after dilution	Prior to initiation, administer a 28-day treatment cycle of cobimetinib 60mg once daily (21 days on, 7 days off) and vemurafenib 960mg twice daily (Days 1–21) and vemurafenib 720mg twice daily (Days 22–28). Give atezolizumab 840mg IV every 2wks until disease progression or unacceptable toxicity, in combination with cobimetinib 60mg once daily (21 days on, 7 days off) and vemurafenib 720mg twice daily.
nivolumab	Opdivo	10mg/mL	soln for IV infusion after dilution	Infuse over 30mins. ≥40kg: 240mg every 2wks or 480mg every 4wks. <40kg: 3mg/kg every 2wks or 6mg/kg every 4wks. Single agent (for unresectable or metastatic melanoma): continue until disease progression or unacceptable toxicity. Adjuvant treatment: continue until disease recurrence or unacceptable toxicity for up to 1yr. In combination with ipilimumab: 1mg/kg (followed by ipilimumab on the same day) every 3wks for 4 doses, then followed by 240mg every 2wks or 480mg every 4wks (if ≥40kg) or 3mg/kg every 2wks or 6mg/kg every 4wks (if <40kg) as a single agent until disease progression or unacceptable toxicity.
pembrolizumab	Keytruda	25mg/mL	soln for IV infusion after dilution	Infuse over 30mins. 200mg every 3wks or 400mg every 6wks until disease progression or unacceptable toxicity. Adjuvant: continue until disease recurrence, unacceptable toxicity, or up to 12 months.
PD-1 BLOCKING ANTIBODY + LAG-3 BLOCKING ANTIBODY
nivolumab/ relatlimab-rmbw	Opdualag	240mg/80mg per 20mL	soln for IV infusion	Infuse over 30mins. ≥40kg: 480mg/160mg every 4wks until disease progression or unacceptable toxicity.
NOTES
¹ Recombinant. ² For melanoma with BRAF V600E or V600K mutations. ³ For melanoma with BRAF V600 mutation only. Not an inclusive list of medications and/or doses. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. (Rev. 6/2023)

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