Daiichi Sankyo and Plexxikon get FDA nod for melanoma combination

Japan's Daiichi Sankyo and its associated company Plexxikon said the U.S. Food and Drug Administration has approved cobimetinib for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf (vemurafenib), the company said in a statement.

Cobimetinib was developed by Roche's ($RHHBY) Genentech and by Exelixis ($EXEL) and will be used in combination with Zelboraf, which will be co-promoted in the United States by Genentech, Daiichi Sankyo and Exelixis, the company said in its release.

"We are excited to bring a new dual pathway treatment option to patients with BRAF mutation-positive advanced melanoma," said Ken Keller, president of U.S. commercial operations for Daiichi Sankyo, in the statement. "We look forward to strengthening our existing relationship with Genentech with the ultimate goal of benefiting patients with advanced melanoma."

The company also said in its statement that FDA approval "was based on results from the Phase III coBRIM study, which showed cobimetinib plus Zelboraf reduced the risk of the disease worsening or death … by about half in people who received the combination."

"This FDA approval underscores the importance of combining two different targeted medicines to help delay disease progression and help people live longer," said Gideon Bollag, Plexxikon's CEO.

- here's the release

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