Rucaparib for Advanced BRCA–Mutated Ovarian Cancer Granted FDA Priority Review

Rucaparib for Advanced BRCA–Mutated Ovarian Cancer Granted FDA Priority Review
The US Food and Drug Administration (FDA) has recently granted priority review to Rucaparib for the treatment of patients with advanced ovarian cancer who have germline or somatic BRCA–mutated tumors. Rucaparib was granted FDA’a Breakthrough Therapy Designation for this indication in April 2015. The therapy by Clovis Oncology 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”. The FDA’s priority review designation allows advanced ovarian cancer patients who have been previously treated with two or more lines of platinum-based therapy to receive rucaparib treatment. The FDA’s filing decision is expected for Feb. 23, 2017. “The acceptance of the rucaparib new drug application submission represents an important milestone for rucaparib, and for Clovis,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release. “There is tremendous need for additional therapeutic options for patients with advanced (BRCA–mutant) ovarian cancer, and we look forward to cooperating
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