FDA Bypasses Panel Review for Clovis Cancer Drug

Sept. 11, 2016

The FDA notified Colorado-based Clovis Oncology that the agency is not planning to hold an advisory committee meeting to discuss the company’s New Drug Application for rucaparib.

The ovarian cancer drug candidate will not be subjected to an outside panel review, suggesting that the FDA has not found any issues that require outside opinion and that the drug stands a greater chance of quick approval.

Previously announced, the FDA accepted the Clovis’ NDA for accelerated approval of rucaparib and granted priority review status to the application with a PDUFA date of February 23, 2017. Rucaparib was licensed from Pfizer in 2011, and Clovis and Pfizer recently negotiated to defer milestone payments until a later date.