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.
In the data submitted to the FDA, the median PFS with the combination was 12.3 versus 7.2 months for vemurafenib alone (HR, 0.58). At a 17-month analysis, 65% of patients receiving the combination remained alive compared with 50% for vemurafenib. The objective response rate (ORR) with the combination was 69.6% compared with 50% for vemurafenib alone.
"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," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. "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."