FDA Approves Second Targeted Combination Therapy for Advanced Melanoma

On November 10, the US Food and Drug Administration (FDA) approved the combination targeted therapy vemurafenib-cobimetinib (Zelboraf-Cotellic) for about half of all patients with Stage IV melanoma that is inoperable or has metastasized throughout the body.  Approved for patients who have specific mutations in the tumor-promoting BRAF gene, the new therapy works similarly to the first approved combination targeted therapy, dabrafenib-trametinib, approved in 2014. Like dabrafenib, vemurafenib blocks the mutant BRAF gene, while cobimetinib, like trametinib, blocks another gene called MEK that helps promote metastasis. By inhibiting two different parts of the signaling pathway that promotes melanoma metastasis, the new combination therapy delays advance of the disease about 5 months longer (12 months vs. 7 months) than vemurafenib alone. Patients on the combination therapy also lived longer on average than those on vemurafenib alone, with approximately 65 percent of patients alive 17 months after starting treatment, compared to about 50 percent of those taking vemurafenib only.

Published on November 18, 2015