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FDA approves Cotellic as part of combination regimen for advanced melanoma
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The FDA today approved cobimetinib to be used in combination with vemurafenib for the treatment of advanced melanoma.
The cobimetinib (Cotellic, Genentech) and vemurafenib (Zelboraf; Genentech, Daiichi-Sankyo) treatment regimen is intended for patients with BRAF V600E- or V600K-positive melanoma whose disease has metastasized or cannot be removed by surgery.
Melanoma is the most dangerous form of skin cancer in the U.S. Approximately 73,800 Americans will be diagnosed with melanoma this year and approximately 9,000 people will die of the disease, according to NCI estimates.
Cobimetinib prevents or slows cancer cell growth by inhibiting MEK activity, which is part of a signaling pathway. Vemurafenib — which the FDA approved in 2011 — is a BRAF inhibitor that affects a different part of the same pathway.
The FDA based its decision in part on the results of a randomized clinical trial that included data from 495 patients with previously untreated, BRAF mutation-positive melanoma. All patients received vemurafenib, followed by cobimetinib or placebo.
In the trial, patients assigned cobimetinib experienced a longer time to disease progression than those assigned placebo (12.3 months vs. 7.2 months). Further, more patients in the cobimetinib arm achieved 17-month OS (65% vs. 50%) and experienced complete or partial tumor shrinkage (70% vs. 50%).
Adverse events associated with cobimetinib plus vemurafenib include diarrhea, photosensitivity reaction, nausea, fever and vomiting.
“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,” Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”