fdaThe US Food and Drug Administration (FDA) approved Cotellic (cobimetinib) to be used in combination with vemurafenib for the treatment of advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).

“[The] approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma,” says Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a news release.

Cotellic blocks the activity of an enzyme known as MEK, which is part of a larger signaling pathway. Abnormal activity of signaling pathways can lead to cancer. Cotellic prevents or slows cancer cell growth. Vemurafenib, marketed in the US as Zelboraf, is a BRAF inhibitor that affects a different part of the same pathway. It was approved in 2011 to treat patients with melanoma that has spread to other parts of the body or cannot be removed by surgery, whose tumors express a gene mutation called BRAF V600E, as detected by an FDA-approved test.

Healthcare providers should confirm the presence of BRAF V600 E or V600K mutation in their patients’ tumor specimens using one of the available FDA-approved tests prior to starting treatment with Cotellic in combination with vemurafenib.

The safety and efficacy of Cotellic taken in combination with vemurafenib were demonstrated in a randomized clinical study of 495 patients with previously untreated, BRAF V600 mutation-positive melanoma that is advanced or cannot be removed by surgery. All study participants received vemurafenib and were then randomly selected to also take either Cotellic or a placebo. On average, 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 starting treatment), compared to approximately 7.2 months after starting treatment for those taking vemurafenib only. In addition, patients taking Cotellic plus vemurafenib lived longer, with approximately 65% of patients alive 17 months after starting treatment as compared to half of those taking vemurafenib only. Additionally, 70% of those taking Cotellic plus vemurafenib experienced complete or partial shrinkage of their tumors, compared to 50% among those taking vemurafenib plus placebo.

The most common side effects of treatment with Cotellic in combination with vemurafenib are diarrhea, sensitivity to ultraviolet (UV) light, nausea, fever, and vomiting. Cotellic may cause severe side effects, including cardiomyopathy, rhabdomyolysis, primary cutaneous malignancies, retinal detachment, severe skin rash, hepatotoxicity, hemorrhage, and severe skin rash due to increased photosensitivity. People taking Cotellic should avoid sun exposure and wear protective clothing and a broad spectrum ultraviolet A/ultraviolet B sunscreen to protect against sunburn. Women taking Cotellic should use effective contraception, as the medication can cause harm to a developing fetus.

Cotellic and Zelboraf are both marketed by Genentech of San Francisco.