In BRCA-mutated advanced ovarian cancer after two or more chemotherapies,
Tailoring therapy to fit more women
For women with BRCA-mutated advanced ovarian cancer after two or more chemotherapies,
Tailored for response, designed to endure
Rubraca is the first FDA-approved PARP therapy to treat both germline and somatic BRCA-mutated tumors1
- Objective response rate for the total population was 54%
(95% CI [44, 64])1
- Complete response rate for the total population was 9%1
- Partial response rate for the total population was 45%1
- Median duration of response for the total population was 9.2 months (95% CI [6.6, 11.6])1
- Response assessment by independent radiology review was 42% (95% CI [32, 52]), with a median DOR of 6.7 months (95% CI [5.5, 11.1])
Rubraca is indicated as monotherapy for the treatment of patients with deleterious BRCA mutation
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
The efficacy of Rubraca was investigated in 106 patients in two multicenter, single-arm, open-label clinical trials, Study 1 and Study 2, in patients with advanced BRCA-mutant ovarian cancer who had progressed after 2 or more prior chemotherapies. All 106 patients received Rubraca 600 mg orally twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator and independent radiology review (IRR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.1
gBRCA, germline BRCA; sBRCA, somatic BRCA.
1. Rubraca [prescribing information]. Boulder, CO: Clovis Oncology; 2017.