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FDA Approves Rucaparib for Ovarian Cancer

Jason M. Broderick @jasoncology
Published: Monday, Dec 19, 2016

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has granted an accelerated approval to rucaparib (Rubraca) as a treatment for patients with BRCA-positive advanced ovarian cancer who have received at least 2 prior lines of chemotherapy, according to Clovis, the manufacturer of the PARP inhibitor.

-positive ovarian, fallopian tube, or primary peritoneal cancer, who have received at least 2 prior platinum-based chemotherapy regimens.

The PARP inhibitor is also being explored in prostate, breast, and gastroesophageal cancers.

“We believe that today’s approval of Rubraca provides an important new therapy for advanced ovarian cancer patients with a germline or somatic mutation of BRCA after 2 or more chemotherapies,” Patrick J. Mahaffy, CEO and president of Clovis Oncology, said in a statement. “We look forward to launching Rubraca with the support of our established US commercial and medical affairs organizations and bringing this much-needed precision medicine to women with advanced ovarian cancer as quickly as possible.”

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