On February 19, 2015 Roche reported that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma (Press release Hoffmann-La Roche , FEB 18, 2015, View Source [SID:1234501708]). The FDA will make a decision on approval by August 11, 2015.

“We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it priority review status,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “We look forward to working with the FDA to bring this new treatment option to people with BRAF mutation-positive advanced melanoma as soon as possible.”

A priority review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The NDA is based on results of the coBRIM Phase III study, which showed the MEK inhibitor cobimetinib plus Zelboraf reduced the risk of disease worsening or death by half in people who received the combination (hazard ratio [HR]=0.51, 95 percent confidence interval [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. The safety profile was consistent with a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab value abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab value abnormalities.