publication date: Sep. 5, 2014


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Accelerated Approval Granted To Keytruda in Metastatic Melanoma

FDA granted accelerated approval for Keytruda (pembrolizumab) for unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

The indication was approved based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Keytruda received a Breakthrough Therapy designation for advanced melanoma, and is the first anti-programmed death receptor-1 therapy approved in the U.S.

The designation was granted based on the significance of early study findings and the unmet medical need. For the recommended 2 mg/kg dose based on data in 89 patients, the overall response rate was 24 percent (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At the time of analysis, 86 percent (18/21) of patients with objective responses had ongoing responses with durations ranging from 1.4+ to 8.5+ months, including eight patients with ongoing responses of 6 months or longer. Fourteen percent (3/21) had progression of disease 2.8, 2.9, and 8.2 months after initial response.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumor cells and healthy cells. Immune-mediated adverse reactions occurred with Keytruda including pneumonitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism.

Merck, the drug’s sponsor, is conducting ongoing phase II and III clinical studies in advanced melanoma.


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