Melanoma: New Combination Drug Treatment FDA-Approved To Treat Patients

The Food and Drug Administration (FDA) has approved a new drug combination treatment for melanoma patients.

The combination involves the drugs Cotellic (cobimetinib) with Zelboraf (vemurafenib)--both drugs that are manufactured by the Swiss company Roche for patients with BRAF V600K or BRAF V600E mutation-positive advanced melanoma. In patients affected by these mutations, the cancer has already spread and cannot be helped by surgery alone, researchers say.

Cotellic works by blocking the activity of the enzyme MEK, which is part of a larger signaling pathway. Meanwhile, vemurafenib is a BRAF inhibitor that affects a different part of the same pathway.

"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," said Richard Pazdur, M.D. reported in a news release. "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."

A Phase III clinical trial involving 495 patients showed that people on the drug combination treatment plan typically lived longer than those who just took Zelboarf. In fact, after 17 months, 65 percent of the drug-combination group was still alive. However, the targeted treatment group only showed the rate at 50 percent.

Patients on the combination therapy also lived for a longer period of time than those taking Zelboraf before their cancer worsened. While patients only taking Zelboarf experienced worsened conditions after 7.2 months, the combination group showed worsened conditions from their cancer after 12.3 months. 

Common side effects associated with the drugs range from fever to vomiting, diarrhea, nausea and sensitivity to ultraviolet light. 

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