Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRCA2 pathogenic variants status confers therapeutic sensitivity to Rucaparib in patients with High-Grade Serous Fallopian Tube Cancer.

The U.S. Food and Drug Administration granted approval to rucaparib for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

This statement is based on a regulatory approval from the Food and Drug Administration:

RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Citation

Clovis Oncology, Inc. Rubraca (rucaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209115s014s015lbl.pdf. Revised December 2025. Accessed December 23, 2025. Clovis Oncology, Inc. Rubraca (rucaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209115s003lbl.pdf. Revised April 2018. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-04-06	Food and Drug Administration	Indication received traditional approval.