September 04, 2014
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FDA approves Keytruda for advanced melanoma

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The FDA today announced the accelerated approval of pembrolizumab, a PD-1 inhibitor, for patients with advanced or unresectable melanoma following progression with prior therapies.

Pembrolizumab (Keytruda, Merck) is intended for patients who have previously been treated with ipilimumab (Yervoy, Bristol-Myers Squibb). Among patients whose tumors harbor a BRAF V600 mutation, pembrolizumab is intended to follow treatment with ipilimumab and a BRAF inhibitor.

Richard Pazdur, MD

Richard Pazdur

“Keytruda is the sixth new melanoma treatment approved since 2011, a result of promising advances in melanoma research,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Many of these treatments have different mechanisms of action and bring new options to patients with melanoma.” 

The approval was based in part on results from a combined clinical trial, designed to evaluate the effectiveness of pembrolizumab in 173 patients with advanced melanoma whose disease progressed after prior treatment. Researchers randomly assigned patients to the 2 mg/kg- recommended dose of pembrolizumab or a higher dose of 10 mg/kg.

According to study results, of the patients who received the recommended dose, 24% exhibited tumor shrinkage, with a response duration lasting from 1.4 to 8.5 months. Similarly, patients who received the 10 mg/kg dosage also experienced tumor shrinkage.

The safety of pembrolizumab was established in the trial population of 411 participants with advanced melanoma. Gastrointestinal symptoms such as diarrhea, nausea, decreased appetite and constipation were the most commonly observed adverse events among study participants, as well as fatigue, cough, pruritus, rash and arthralgia.

Pembrolizumab also has the potential for severe immune-mediated adverse effects. Among the 411 participants in the trial, severe immune-mediated adverse effects involving healthy organs, including the lung, colon, hormone-producing glands and liver, occurred uncommonly.