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News From the Food and Drug Administration
February 7, 2017

Ovarian Cancer Drug Approved

JAMA. 2017;317(5):466. doi:10.1001/jama.2017.0026

Certain women with advanced ovarian cancer whose tumors haven’t responded to at least 2 chemotherapy drugs have a new FDA-approved treatment option.

The agency gave the nod to rucaparib for treating ovarian tumors with harmful BRCA gene mutations. Marketed as Rubraca, the drug was approved along with a companion diagnostic test used to detect the mutations. The agency granted the drug accelerated approval, which is given to treatments for serious illnesses based on a surrogate end point likely to predict clinical benefit.