FDA Grants Accelerated Approval To Rucaparib

• Amanda Bridges
• December 22, 2016
• Drugs

On December 19, 2016, the U.S. Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA™, Clovis Oncology Inc.) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.

In conjunction with the drug approval, FDA approved the FoundationFocus™ CDxBRCA test (Foundation Medicine Inc.), the first FDA-approved next-generation sequencing (NGS)-based companion diagnostic to identify patients with advanced ovarian cancer eligible for treatment with rucaparib. The test detects alterations in BRCA1 and BRCA2 genes in the tumor tissue of ovarian cancer patients. Click here to read full article.  For FDA Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm533891.htm