The U.S. Food and Drug Administration (FDA) accepted a New Drug Application for accelerated approval of rucaparib, and granted priority review status to the application, Clovis Oncology announced.1
Clovis Oncology is seeking approval for rucaparib for the treatment of advanced ovarian cancer among patients with deleterious BRCA mutation-positive tumors, inclusive of both germline and somatic BRCA mutations, and who have received at least 2 prior lines of chemotherapy.
The New Drug Application is based on findings from 2 multicenter, single-arm, open-label clinical trials that evaluated the efficacy of rucaparib in 106 patients. Overall, 54% (95% CI, 44-64) achieved an objective response, and 9% of patients achieved a complete response.
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The most common grade 3 to 4 treatment-emergent adverse events include anemia, asthenia, and increased alanine transaminase/aspartate transaminase.
- FDA accepts Clovis Oncology’s New Drug Application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer. Clovis Oncology website. http://phx.corporate-ir.net/phoenix.zhtml?c=247187&p=irol-newsArticle&ID=2196955. Updated August 23, 2016. Accessed August 25, 2016.