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FDA Approves Nivolumab as Adjuvant Treatment for Melanoma

Approval granted for patients aged 12 years and older with stage IIB/C disease

By Lori Solomon (HealthDay News) | October 18, 2023

WEDNESDAY, Oct. 18, 2023 (HealthDay News) -- The U.S. Food and Drug Administration has approved Opdivo (nivolumab) for the adjuvant treatment of completely resected stage IIB/C melanoma in patients ages 12 years and older.

The approval was based on results from the CHECKMATE-76K randomized, double-blind trial. The trial included 790 patients with stage IIB/C melanoma who were randomly assigned (2:1) to nivolumab 480 mg or placebo by intravenous infusion every four weeks for up to one year or until disease recurrence or unacceptable toxicity. At the time of the approval, median recurrence-free survival was not reached in either the nivolumab arm or the placebo arm.

The recommended nivolumab dose for patients weighing ≥40 kg is 240 mg every two weeks or 480 mg every four weeks until disease progression or unacceptable toxicity for up to one year. For pediatric patients weighing <40 kg, the recommended dose is 3 mg/kg every two weeks or 6 mg/kg every four weeks.

The most common adverse reactions (reported in at least 20 percent of patients) included fatigue, musculoskeletal pain, rash, diarrhea, and pruritis.

Approval of nivolumab was granted to Bristol Myers Squibb.

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