Melanoma FDA Approvals

3/18/2022: FDA approved OPDUALAG™ (nivolumab and relatlimab-rmb w, Bristol-Myers Squibb) to treat unresectable or metastatic melanoma.

OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

Recommended Dosage:
• Adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg: 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks.
• Administer OPDUALAG as an intravenous infusion over 30 minutes.

Learn more in the FDA label here.  

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1/25/2022: FDA approved KIMMTRAK® (tebentafusp-tebn, Immunocore) to treat unresectable or metastatic uveal melanoma.

KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Recommended dosage: 20 mcg intravenously on Day 1, 30 mcg intravenously on Day 8, 68 mcg intravenously on Day 15, and 68 mcg intravenously once every week there after.

Learn more in the FDA label here.