"Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test." - FDA (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm)
Rubraca (rucaparib) is a PARP (poly ADP-ribose polymerase) inhibitor made by Clovis Oncology. The approval is based on two trials. One of the trials is the ARIEL2 trial. In that trial the duration of response was 11.6 months.
Along with Rubraca, the FDA also approved the FoundationFocus™ CDxBRCA companion diagnostic to identify those women diagnosed with ovarian cancer who have a BRCA mutation. This is the first next-generation-sequencing (NGS)-based companion diagnostic approved by the FDA. The test by Foundation Medicine, Inc. can test for both germline and somatic BRCA mutations in tumor tissue. Germline are inherited mutations and somatic are acquired mutations.
Cure Today: http://www.curetoday.com/articles/rubraca-approved-for-advanced-ovarian-cancer?utm_source=Informz&utm_medium=Cure+Today&utm_campaign=CURE_Breaking_News_12-19-16#undefined.uxfs
Street Insider : http://www.streetinsider.com/Corporate+News/Foundation+Medicine+(FMI)+Announces+FDA+Approval+of+FoundationFocus,+Companion+Diagnostic+for+Rubraca/12356799.html
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