The approval comes after a priority review of the combination that blocks activity of 2 MAPK proteins: BRAF and MEK.
Advanced metastatic, unresectable melanoma in patients whose tumor harbors mutated BRAF (V600E or V600K), have a new option: the combination of vemurafenib and cobimetinib was today, approved by the FDA for this patient population.
"As we continue to advance our knowledge of tumor biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies. Combining two or more treatments addressing different cancer-causing targets may help to address this challenge," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Today’s approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma."
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