Cotellic approved as part of combo treatment for advanced melanoma

November 18, 2015

FDA has approved cobimetinib (Cotellic, Genentech) to be used in combination with vemurafenib (Zelboraf) for the treatment of advanced melanoma.

FDA has approved cobimetinib (Cotellic, Genentech) to be used in combination with vemurafenib (Zelboraf) for the treatment of advanced melanoma.

Related: FDA approves Keytruda for advanced melanoma

Melanoma, the most dangerous and deadly form of skin cancer, develops when unrepaired DNA damage to skin cells triggers mutations that lead to rapidly multiplying cells and the formation of malignant tumors. If melanoma is recognized and treated early, it is almost always curable, but if not, the cancer can metastasize to other parts of the body and become more difficult to treat. The National Cancer Institute estimates that more than 73,000 Americans will be diagnosed and more than 9,000 will die from melanoma this year.

Cotellic is an antineoplastic agent known as a MEK inhibitor that acts by blocking the activity of the enzyme, MEK, which is part of a signaling pathway, that when disrupted can lead to cancer. By blocking the activity of MEK, Cotellic prevents or slows cancer cell growth. Vemurafenib, which was previously approved in 2011, is known as a BRAF inhibitor and affects a different part of the same signaling pathway. Cotellic is now approved, in combination with vemurafenib, for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approximately 50% of melanomas are BRAF-positive and are thus suited for treatment with the combination.

Related:FDA expands use of melanoma drug

“When used in combination, Cotellic and Zelboraf help delay disease progression and help people live significantly longer than with Zelboraf alone,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”

FDA's approval of Cotellic, taken with vemurafenib, was based on a clinical study of 495 patients with previously untreated, BRAF V600 mutation-positive, metastatic, or unresectable melanoma. Patients first received vemurafenib, and then were randomly assigned to receive either Cotellic or placebo. Results showed that patients taking Cotellic plus vemurafenib experienced a delay in the amount of time it took for their disease to worsen; approximately 12.3 months after initiation of treatment compared to approximately 7.2 months for patients taking vemurafenib only. Additionally, 70% of those treated with Cotellic experienced complete or partial shrinkage of their tumors, compared to 50% for the placebo group.

Diarrhea, photosensitivity, nausea, fever, and vomiting are the most common side effects associated with the use of this drug. People taking it should avoid sun exposure, wear protective clothing, and a broad-spectrum sunscreen to protect against sunburn. Effective contraception should also be used by women taking the drug, as it can cause harm to a developing fetus.