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On September 4, 2014, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. According to the FDA, the drug “is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAFV600, [pembrolizumab] is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.” Pembrolizumab was granted breakthrough therapy designation because it may offer a major improvement over currently available agents.
Pembrolizumab is a humanized monoclonal antibody directed against the programmed death 1 (PD-1) receptor. Both laboratory and clinical studies have shown that blocking PD-1 activity leads to a significant increase in antitumor response, especially in melanoma. Pembrolizumab is among six new therapies to receive FDA approval in recent years, including ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), and trametinib (2013).
FDA approves Keytruda for advanced melanoma: First PD-1 blocking drug to receive agency approval [press release]. Silver Spring, MD: U.S. Food and Drug Administration; September 4, 2014. (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm)
Comment
This is an exciting event, although its advent has been expected since the first extraordinary breakthroughs in immune “checkpoint” therapy. The key to ongoing efforts in melanoma, and perhaps many other cancers, is the judicious combination of molecular and immune therapies.