Pharmaceutical Technology

September 5, 2014 6:43 PM

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Merck announced on Sept. 4, 2014 that FDA approved KEYTRUDA (pembrolizumab) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States. For the recommended dose of 2 mg/kg every three weeks based on data in 89 patients, the overall response rate was 24% (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At...

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