FDA Expands Pembrolizumab Label for Melanoma

Source: Cancer Network. January 2016

The US Food and Drug Administration (FDA) recently expanded its approval of pembrolizumab (Keytruda) to include the initial treatment of patients with unresectable or metastatic melanoma. In 2014, pembrolizumab was approved for patients with unresectable or metastatic melanoma who progressed after treatment with ipilimumab and, if BRAF V600–mutation positive, a BRAF inhibitor.

According to the FDA website, this most recent approval was based on evidence from two clinical trials.

The first trial, KEYNOTE-006, was published last year in the New England Journal of Medicine. The phase III trial randomly assigned 834 patients to pembrolizumab 10 mg/kg every 2 weeks, pembrolizumab every 3 weeks, or four doses of ipilimumab 3 mg/kg every 3 weeks.