Cotellic Approved by FDA to Fight Certain Forms of Melanoma

Cotellic Approved by FDA to Fight Certain Forms of Melanoma
November 12, 2015

The Food and Drug Administration (FDA) has issued an approval for Cotellic, a new treatment option for individuals suffering through melanoma.

Cotellic is intended for use in combination with vemurafenib, a common melanoma drug, to treat 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).

"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. Combining two or more treatments addressing different cancer-causing targets may help to address this challenge," Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a written statement. "Today's approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma."

Cotellic works by blocking 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.

The safety and efficacy of the drug was evaluated in a randomized, 495-patient study. 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 those taking vemurafenib only (7.2 months).

The most common side effects of treatment with Cotellic are diarrhea, sensitivity to ultraviolet (UV) light (photosensitivity reaction), nausea, fever (pyrexia) and vomiting.

Cotellic was reviewed under the FDA's priority review program that provides for an expedited six-month review of drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Cotellic also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.

Skin cancer is the most common form of cancer in the United States, and melanoma, caused by exposure to ultraviolet light, is its most deadly form. According to the National Cancer Institute, approximately 74,000 Americans will be diagnosed with melanoma and nearly 10,000 will die from the disease in 2015.