FDA Approves New Melanoma Treatment

FDA Approves New Melanoma Treatment
FDA Approves New Melanoma Treatment

The U.S. Food and Drug Administration (FDA) has approved Cotellic (cobimetinib; Genentech) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf (vemurafenib).

The safety and efficacy of Cotellic taken in combination with vemurafenib were demonstrated in a randomized clinical study of 495 patients with previously untreated, BRAF V600 mutation-positive melanoma that is advanced or cannot be removed by surgery. 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 approximately 7.2 months after starting treatment for those taking vemurafenib only. In addition, patients taking Cotellic plus vemurafenib lived longer, with approximately 65% of patients alive 17 months after starting treatment as compared to half of those taking vemurafenib only. Additionally, 70% of those taking Cotellic plus vemurafenib experienced complete or partial shrinkage of their tumors, compared to 50% among those taking vemurafenib plus placebo.

Cobimetinib is a reversible inhibitor of mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase 1 (MEK 1) and MEK2. MEK protein are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. Cobimetinib and vemurafenib target two different kinases in the RAS/RAF/MEK/ERK pathway.

Healthcare providers should confirm the presence of BRAF V600 E or V600K mutation in their patients' tumor specimens using one of the available FDA approved tests prior to starting treatment with Cotellic in combination with vemurafenib.

For more information visit Gene.com.

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