FDA delays action date on Roche/Exilixis' cobimetinib by three months

2 July 2015

The US Food and Drug Administration (FDA) has postponed the action date for the regulatory filing of cobimetinib from Roche (SIX: ROG) and Exelixis (Nasdaq: EXEL) by three months.

Exelixis said the FDA has extended its review after Roche’s Genentech division complied with a request to submit additional data from its Phase III coBRIM study to test the experimental MEK inhibitor in combination with Roche’s BRAF inhibitor Zelboraf (vemurafenib) in BRAF V600 mutation-positive advanced melanoma.

Roche submitted cobimetinib for FDA approval in combination with Zelboraf for this indication last December, and it was granted priority review earlier this year.

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