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CLVS > Clovis Oncology Says FDA Grants Priority Review Status for Rubraca
8:09 am ET January 15, 2020 (Dow Jones) Print
By Chris Wack

Clovis Oncology Inc. (CLVS) said Wednesday the U.S. Food and Drug Administration has accepted the company's supplemental New Drug Application for Rubraca rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act date of May 15.

The company said it submitted the supplemental application for rucaparib as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.

A priority review designation is granted to proposed medicines that the FDA has determined have the potential, if approved, to offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. Priority designation shortens the review period from the standard 10 months to six months.

Clovis shares were up 1% to $8.95 premarket.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires