FDA approves pembrolizumab for completely resected melanoma


The Food and Drug Administration has approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following resection.

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FDA approval is based on results from the randomized, double-blind, placebo-controlled EORTC1325/KEYNOTE‑054 trial, in which 1,019 patients with completely resected stage III melanoma received either a placebo or 200 mg of pembrolizumab every 3 weeks for up to 1 year until disease recurrence or unacceptable toxicity.

Recurrence-free survival was significantly better in the pembrolizumab group than in the placebo group (hazard ratio, 0.57; 95% confidence interval, 0.46-0.70; P less than .001). The median recurrence-free survival time was 20.4 months in the placebo group and was not reached in the pembrolizumab group, the FDA said in a press release.

About three-quarters of patients received pembrolizumab for at least 6 months, while 14% of patients had to stop pembrolizumab treatment because of adverse events. The most common adverse events in pembrolizumab-treated patients included diarrhea, pruritus, nausea, arthralgia, hypothyroidism, cough, rash, asthenia, influenzalike illness, weight loss, and hyperthyroidism.

“The recommended pembrolizumab dose and schedule for the adjuvant treatment of melanoma is 200 mg administered as an IV infusion over 30 minutes every 3 weeks until disease recurrence or unacceptable toxicity, for a maximum of 1 year,” the FDA said in the press release.

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