Rucaparib Receives Breakthrough Therapy Designation from FDA

(April 14, 2015) The FDA granted breakthrough therapy designation to rucaparib as monotherapy for patients with advanced ovarian cancer. Rucaparib is an oral, small-molecule PARP inhibitor developed for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors that have BRCA mutations and other DNA deficiencies commonly referred to as “BRCA-like.”

An FDA-designated “breakthrough therapy” is a drug to treat a serious or life threatening disease or condition, and which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.  If a drug is designated as breakthrough therapy, the FDA will expedite the development and review of such drug.

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