Genentech announced that FDA has approved Cotellic (cobimetinib) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf (vemurafenib).

Phase III Study Results: Cotellic plus Zelboraf reduced the risk of disease worsening or death by about half in people who received the combination (HR=0.56), with a median progression-free survival of 12.3 months for Cotellic plus Zelboraf compared to 7.2 months with Zelboraf alone. Analysis also showed the combination of Cotellic and Zelboraf helped people live significantly longer than Zelboraf alone (HR=0.56). The objective response rate was higher with Cotellic plus Zelboraf compared to Zelboraf alone (70 vs. 50%), as was the complete response rate (16 vs. 10%).

Side Effects: Possible serious side effects with Cotellic include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of Cotellic include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. Cotellic can also cause changes in blood test results.

Citation: FDA approves Genentech’s Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) in advanced melanoma. [news release]. South San Francisco, CA: Genentech; November 10, 2015. http://www.gene.com/media/press-releases/14611/2015-11-10/fda-approves-genentechs-cotellic-cobimet. Accessed November 10, 2015.