FDA Grants Rubraca Speedy Review for Use as Ovarian Cancer Maintenance Treatment

FDA Grants Rubraca Speedy Review for Use as Ovarian Cancer Maintenance Treatment
The U.S. Food and Drug Administration (FDA) has granted Priority Review Status to Clovis Oncology’s application to expand its approval for Rubraca (rucaparib) to include recurrent ovarian cancer maintenance treatment. A decision is expected by April 6, 2018. Clovis submitted the application, which specifies that the maintenance treatment should be used in women who are sensitive to platinum-based chemotherapy, in October 2017. “We are pleased that we continue to make significant progress toward our goal of delivering rucaparib to a much broader population of women with advanced ovarian cancer,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release. “We are particularly encouraged by the FDA’s decision to grant priority review to the application, which may allow us to make rucaparib available to these women in a more expeditious manner.” The priority designation shortens the time the FDA requires to review an application from 10 months to six months, and is granted to drugs that provide a considerable improvement in the safety or effectiveness of a treatment for a serious condition. The so-called supplemental New Drug Application was based on data from the Phase 3 ARIEL3 trial (
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