FDA Approves Targeted Therapy Combination for Melanoma

May 22, 2017

Just over a month after approving a first-of-its-kind combination therapy for advanced melanoma, the U.S. Food and Drug Administration (FDA) has signed off on another drug combination to treat the disease.

Skin cancer screeningsThe FDA has approved a targeted therapy combination, Cotellic (cobimetinib) and vemurafenib, to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery. The therapy targets a certain type of abnormal gene: BRAF V600E or V600K mutation.

“Treatment for melanoma is advancing at a record pace, with numerous new and exciting options for patients,” says Elizabeth Buchbinder, MD, a physician with Dana-Farber’s Melanoma Treatment Center. “The landscape for metastatic melanoma has been changing dramatically in a setting where there were previously only a few treatments available.”

In early October 2015, the FDA approved the first cancer treatment to combine two immunotherapy drugs: ipilimumab (Yervoy) and nivolumab (Opdivo). The immunotherapeutic combination has been approved to treat certain patients with unresectable or metastatic melanoma. Specifically, it is approved for patients who have tumors that do not harbor the BRAF V600 mutations found in about 50 percent of melanomas.