FDA Accepts Keytruda sBLA for First-Line Melanoma Indication

Merck announced that the Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) at the currently approved dose of 2mg/kg every three weeks as a first-line treatment of unresectable or metastatic melanoma.

The sBLA submission for first-line use in advanced melanoma was based in part on data from KEYNOTE-006, a Phase 3 study which evaluated Keytruda in 834 patients with unresectable or metastatic melanoma with progression of disease. Findings from this study were presented at the 2015 American Associated for Cancer Research (AACR) Annual Meeting and published in the New England Journal of Medicine.

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Keytruda, a humanized monoclonal PD-1 inhibitor antibody, is currently indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

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