FDA Okays Genentech's Cotellic In Combination With Zelboraf In Advanced Melanoma

(RTTNews) - Genentech, a member of the Roche Group (RHHBY.PK), announced that the U.S. Food and Drug Administration approved Cotellic or cobimetinib for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf or vemurafenib. Cotellic will be available to people in the United States within two weeks.

Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. Cotellic is Genentech's seventh new medicine approved by the FDA in the past five years.

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.

COTELLIC is a selective inhibitor of MEK that was discovered by Exelixis Inc. (EXEL) and is the subject of a worldwide collaboration agreement between Exelixis and Genentech, a member of the Roche Group. This is the second regulatory approval for COTELLIC, which was first approved in Switzerland in late August 2015.