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FDA Updates

FDA approves new immunotherapy for metastatic melanoma

The FDA approved a combination nivolumab/relatlimab-rmbw immune checkpoint inhibitor (Opdualag) for unresectable or metastatic melanoma in adults and children 12 years or older.

Dose: 480 mg nivolumab + 160 mg relatlimab IV every 4 weeks.

Adverse effects: Musculoskeletal pain, fatigue, rash, pruritus, and diarrhea were the most common adverse reactions with combination nivolumab/relatlimab, occurring in 20% or more of RELATIVITY-047 trial participants. Adrenal insufficiency, anemia, colitis, pneumonia, and myocardial infarction were the most frequent serious adverse reactions, but each occurred in less than 2% of patients. There were three fatal adverse events in the trial due to hemophagocytic lymphohistiocytosis, acute lung edema, and pneumonitis.

Source: BMS

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