New melanoma drug Cotellic from Roche approved by the FDA

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The Food and Drug Administration has approved Roche's Cottelic drug to be used as a combination treatment for advanced melanoma skin cancer.

Cotellic (cobimetinib) is produced by the Swiss drug manufacturer Roche. It will be given in tandem with the company's Zelboraf (vemurafenib) drug to treat a particularly advanced type of melanoma that is inoperable and has an abnormal gene mutation, the US Food and Drug Administration (FDA) announced on Tuesday.

"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," said Dr. Richard Pazdur of the FDA's Center for Drug Evaluation and Research in a statement. "Combining two or more treatments addressing different cancer-causing targets may help to address this challenge.

"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."

The drug combination showed promise as an effective melanoma skin cancer treatment after it did well in patients during a clinical trial. It was given a "priority review" status after it prevented and slowed down the growth of secondary tumors in some cancer patients, according to UPI.

Melanoma is considered to be the most dangerous form of skin cancer. According to Skin Cancer Foundation, it can be caused by exposure to ultraviolet radiation such as in tanning beds or from the sun. Melanomas can resemble moles and are usually black, brown or skin-colored. However, there have been cases where it can look purple, white, blue, or pink.

Melanoma kills nearly 10,000 people in the United States every year. In 2015, it is estimated that there will be more than 130,000 new cases of the advanced skin cancer with more than half being invasive melanomas.

According to the FDA, Cotellic blocks the enzyme MEK to help prevent or slow down the growth of melanoma. Zelboraf was already approved in 2011 for patients with metastasized skin cancer or those with inoperable tumors or gene mutation. It inhibits another critical part of the same pathway.

During the drugs' clinical testing of nearly 500 people that were divided in three group, those who took the Cotellic/Zelboraf drug combination outlived other groups by an average 12.3 months. Those who took Zelboraf alone had a delayed cancer progression of only 7.2 months, according to Health Day. The Cotellic/Zelboraf had a better survival rate as 65 percent were still alive after more than 1 and a half years compared to the other group which only had half the survivors.