FDA approves Genentech’s Cotellic as part of melanoma combo

“As we continue to advance our knowledge of tumour biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies”.

The combination of Cotellic with Zelboraf helps patients with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year (12.3 months) without their disease worsening, compared to 7.2 months with Zelboraf alone.

Diplomat Pharmacy announced Wednesday that it will dispense Cotellic (cobimetinib) in combination with the BRAF inhibitor Zelboraf (vemurafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (cancer that has spread from the primary site). “Combining two or more treatments addressing different cancer-causing targets may help to address this challenge”, said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Now what: The market for Cometriq in MTC is undeniably tiny and as a result, Exelixis investors have been eagerly awaiting the approval of Cotellic to help strengthen Exelixis’ financials.

Tumour shrinkage was also higher in the group receiving the combo compared to those taking Zelboraf alone (70% versus 50%), and complete tumour shrinkage was observed in 16% versus 11%, respectively. And about 65 percent of people who took the drug combination were still alive after 17 months, compared to 50 percent of people who took the single drug and a placebo, the FDA said. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and laboratory test abnormalities.

The combination was so effective with patients in a clinical trial the FDA granted it “priority review” status to speed its approval for use with patients. Cotellic will be available to people in the United States within two weeks. Dr. Ribas explained that the study found that when the experimental drug Cotellic is added, the combination works better and for much longer.

Cotellic is used to block an enzyme dubbed MEK which also enables cancer cells to grow.

Genentech also manufactures Zelboraf (vemurafenib).

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.