FDA Approves Drug to Treat Advanced Melanoma

The FDA has approved pembrolizumab (Keytruda) for the treatment of advanced or unresectable melanoma in patients that are no longer responding to other drugs.

Pembrolizumab, granted an accelerated approval due to its treatment of a life-threatening disease and clinical data showing its effects, works by blocking the PD-1 cellular pathway that works to prevent the immune system from attacking melanoma cells.
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It is intended to be used alongside of ipilimumab immunotherapy in with a BRAF inhibitor when used in patients with tumors containing the gene mutation BRAF V600.

The drug was granted “breakthrough therapy” designation by the FDA due to its demonstration of significant improvement over existing treatment options. 

In a study of the drug’s effectiveness, researchers divided 173 participants with progressed melanoma between the recommended dose of 2 mg/kg of pembrolizumab and a higher dose of 10 mg/kg.

Of those receiving the recommended dose, 24% showed shrinkage of their tumors, while only a small percentage of those taking the higher dose saw shrinkage. 

The drugs safety was established in a study of 411 participants with melanoma; the most common side effects include fatigue, cough, nausea, pruritus, joint pain, and diarrhea. 

—Michael Potts

US Food and Drug Administration. FDA approves Keytruda for advanced melanoma [press release]. September 4, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm. Accessed September 5, 2014.