On December 19, 2016, the FDA granted accelerated approval to rucaparib 
(RUBRACA; Clovis Oncology, Inc.) for the treatment of patients with deleterious 
BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer who 
have been treated with two or more chemotherapies. The FDA also approved the 
FoundationFocus CDx BRCA test (Foundation Medicine, Inc.), the first 
next-generation sequencing-based companion diagnostic, for identifying patients 
with advanced ovarian cancer eligible for treatment with rucaparib based on 
detection of deleterious BRCA1 and/or BRCA2 mutations in tumor tissue. 
Rucaparib's approval was based primarily on efficacy data from 106 patients with 
BRCA mutation-associated ovarian cancer who had prior treatment with two or more 
chemotherapies and safety data from 377 patients with ovarian cancer treated 
with rucaparib 600 mg orally twice daily on two open-label, single-arm trials. 
Investigator-assessed objective response rate was 54% [57/106; 95% confidence 
interval (CI), 44-64], and median duration of response was 9.2 months (95% CI, 
6.6-11.7). The approved companion diagnostic verified tumor BRCA mutation status 
retrospectively in 96% (64/67) of patients. Common adverse reactions (≥20%) to 
rucaparib were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, 
constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. This 
article summarizes the FDA review and data supporting rucaparib's accelerated 
approval. Clin Cancer Res; 23(23); 7165-70. ©2017 AACRSee related commentary by 
Kohn et al., p. 7155.