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ArticleFDA Updates

FDA approves Nivolumab for resected stage IIB/C melanoma

The US FDA has approved nivolumab for the treatment of completely resected stage IIB/C melanoma for patients aged 12 years and older, expanding the melanoma indication for the programmed death receptor-1 (PD-1) inhibitor.

Dose – For patients >40 kg,  480 mg every 4 weeks or 240 mg every 2 weeks until disease recurrence or unacceptable toxicity for up to 1 year. For pediatric patients < 40 kg, 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks until disease recurrence or unacceptable toxicity for up to 1 year.

Adverse reactions – fatigue, musculoskeletal pain, rash, diarrhea &  pruritis.

Clinical Inshorts by ClinicHours

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