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FDA Approves Vemurafenib/Cobimetinib Combo for Melanoma

Silas Inman @silasinman
Published: Tuesday, Nov 10, 2015

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has approved the combination of vemurafenib (Zelboraf) and cobimetinib (Cotellic) as a treatment for patients with BRAF-positive metastatic or unresectable melanoma, based on an extension in progression-free survival (PFS) in the phase III coBRIM study.

Patient demographics were well balanced across the two arms for age, ECOG performance status, geographic region, and disease stage. More than half of patients had stage IV, M1c melanoma and the Cobas 4800 BRAF V600 Mutation Test was used to detect BRAF mutations. The primary endpoint for the study was PFS, with secondary endpoints focused on OS, objective response rate (ORR), and duration of response.

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