A New Rx Combo for Melanoma

Cotellic (cobimetinib), from Genentech, approved for use with vemurafenib to treat advanced melanoma

/ Author:  / Reviewed by: Jennifer Gershman, PharmD, CPh

(RxWiki News) There's a new cancer-fighting medication combo in town, and now it's approved to tackle advanced melanoma.

The US Food and Drug Administration (FDA) today approved Cotellic (cobimetinib) for use in conjunction with vemurafenib (brand name Zelboraf) to fight advanced melanoma. Melanoma, the deadliest skin cancer type, is considered advanced when it has spread elsewhere in the body (metastasized) or cannot be removed through surgery.

Richard Pazdur, MD, director of the FDA's Office of Hematology and Oncology Products, said combination treatments like Cotellic with vemurafenib can make a big difference in cancer treatment.

“As we continue to advance our knowledge of tumor biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies," Dr. Pazdur said in a press release. "Combining two or more treatments addressing different cancer-causing targets may help to address this challenge."

Cotellic slows cancer growth by blocking an enzyme called MEK, according to the FDA. Vemurafenib, which gained FDA approval back in 2011, targets a separate gene mutation that can lead to cancer. Genentech markets both drugs.

Together, these two drugs might pack a one-two punch against melanoma. That's what a randomized clinical trial of Cotellic combined with vemurafenib suggested, at least. The FDA approved Cotellic to be used in this combination after the drug, combined with vemurafenib, appeared more effective than vemurafenib alone.

All of the nearly 500 advanced melanoma patients in this study received vemurafenib. But only some received Cotellic, while others received a placebo (fake treatment) in combination with vemurafenib. In the patients who received Cotellic and vemurafenib, melanoma took 12.3 months on average to spread. For those receiving the placebo plus vemurafenib, that figure was 7.2 months.

Patients receiving Cotellic were also more likely to survive for at least 17 months after starting treatment and to see their cancer tumors shrink.

Patients receiving Cotellic reported side effects that included light sensitivity, nausea, vomiting, fever and diarrhea. More severe adverse effects included eye disease, severe rash, liver damage and heart damage, among others. The FDA warned that patients taking Cotellic should avoid unprotected sun exposure. Women should also use effective birth control since Cotellic can cause problems during pregnancy.

Review Date: 
November 10, 2015
Last Updated:
November 11, 2015