Priority Review Granted to Genentech's Combination Melanoma Therapy

The FDA has granted priority review to Genentech’s New Drug Application (NDA) for the use of investigational cobimetinib in combination with vemurafenib (Zelboraf) in advanced melanoma.

Vemurafenib is a prescription medication dedicated to treating melanoma with a mutated BRAF gene, while cobimetinib has been developed to selectively inhibit MEK. The 2 drugs are designed to work together for the treatment of patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.

In a press release, Sandra Horning, MD, chief medical officer and head of global product development, said Genentech “look(s) forward to working with the FDA to bring this new treatment option to people with BRAF mutation-positive advanced melanoma as soon as possible.”

The NDA for cobimetinib plus Zelboraf was based on data from the phase 3 coBRIM study, which demonstrated that the combination treatment reduced the risk of disease worsening or death by half among those who received it.

Adverse side effects seen in the combination arm included lab value abnormalities, elevated creatine phosphokinase, diarrhea, nausea, rash, and photosensitivity.