Cotellic (cobimetinib) in combination with another chemotherapy, vemurafenib (Zelboraf) has been approved by the U.S. Food and Drug Administration to treat melanoma skin cancer that has spread or cannot be surgically removed, the agency said Tuesday in a news release.
Melanoma is the most aggressive and dangerous form of skin cancer. Nearly 74,000 Americans are projected to be diagnosed this year, and nearly 10,000 will die from it, according to U.S. National Cancer Institute estimates cited by the FDA.
Cotellic is designed to block an enzyme dubbed MEK, which when inhibited can help prevent or slow the growth of cancer cells, the agency explained. The anti-melanoma drug vemurafenib was FDA approved in 2011 to treat melanoma among people with a gene mutation called BRAF V600E. Cotellic has been approved for melanoma patients with the same gene mutation, or a second one called V600K.
The FDA said it has approved various tests to confirm the presence of either gene abnormality.
In clinical testing involving 495 people, the Cotellic/Zelboraf combination delayed cancer progression an average of 12.3 months, compared to 7.2 months among those who took Zelboraf alone. 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 side effects of the Cotellic/Zelboraf combination included diarrhea, sensitivity to ultraviolet light, nausea and vomiting, and fever.
Cotellic may cause more serious adverse reactions, including damage to the heart and other muscles, new skin tumors, eye disease and skin rash. Users should avoid sun exposure, and female users of child-bearing age should use contraception since the drug can harm a fetus, the agency warned.
Both Cotellic and Zelboraf are marketed by Genentech, based in San Francisco.
The FDA has more about this approval.