publication date: Dec. 22, 2016
Regulatory Actions FDA Approves Indications for Rubraca and Avastin
FDA granted an accelerated approval to rucaparib (Rubraca) 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.
The drug is sponsored by Clovis Oncology Inc.
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.
Approval of rucaparib and the FoundationFocus CDxBRCA test was based on data from two multicenter, single-arm, open label clinical trials that evaluated the efficacy of rucaparib in 106 patients with advanced ovarian cancer who had progressed after treatment with two or more prior chemotherapies.
During enrollment, BRCA1/2 status was determined using either local germline BRCA test results or a Foundation Medicine clinical trial assay. Formalin-fixed paraffin-embedded tumor tissue samples were collected for testing with the companion diagnostic. Tumor BRCA mutation status was verified retrospectively in 96% (64/67) of the patients for whom a tumor tissue sample was available by the FoundationFocus CDxBRCA test.
All 106 patients received rucaparib 600 mg orally twice daily. Objective response rate and duration of … Continue reading CCL Dec 2016 – FDA Approves Indications for Rubraca and Avastin
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