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FDA Grants Priority Review Designation For Clovis Oncology's Rubraca Label Expansion

FDA Grants Priority Review Designation For Clovis Oncology's Rubraca Label Expansion

Clovis Oncology Inc (NASDAQ: CLVS) shares are advancing strongly after the company clinched a regulatory milestone with respect to its oncology drug Rubraca.

The Boulder, Colorado-based biopharma company that focuses on the development of anti-cancer agents said the FDA has accepted its sNDA for rucaparib as a monotherapy for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer.

Clovis had submitted the regulatory application in November.

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On a more positive note, the FDA has granted priority review status to the sNDA, which serves to shorten the review period from the standard 10 months to six months. Priority review designation is accorded to those therapies, which the FDA considers have the potential to offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition.

Rucaparib, a small oral molecule inhibitor of PARP1, PARP2 and PARP3, being developed for multiple cancer types as monotherapy and in combination with other anti-cancer agents.

It has already been approved as a monotherapy for recurrent epithelial, ovarian, fallopian tube or peritoneal cancer.

Clovis shares were rallying 13% to $10.06.


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