FDA to Review Combination Therapy for Advanced Melanoma

Genentech announced that the FDA has accepted and granted Priority Review to its New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

The NDA submission was based on results from the coBRIM trial, a randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of cobimetinib 60mg once daily in combination with Zelboraf 960mg twice daily, compared to Zelboraf alone. In the study, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma detected by the cobas 4800 BRAF Mutation Test and previously untreated for advanced disease were randomized to receive Zelboraf every day on a 28-day cycle plus either cobimetinib or placebo on days 1–21. The primary endpoint for this study was progression-free survival (PFS).

RELATED: Opdivo Granted Accelerated FDA Approval for Melanoma

Patients who received cobimetinib plus Zelboraf lived significantly longer without disease worsening or death compared to Zelboraf alone. Cobimetinib plus Zelboraf reduced the risk of disease worsening or death by half (HR=0.51, 95% CI 0.39-0.68; P<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone.

For more information call (800) 821-8590 or visit Gene.com.