Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that BRCA2 oncogenic variants status confers therapeutic sensitivity to Rucaparib in patients with Peritoneal Serous Carcinoma.

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/2022/209115s013lbl.pdf. Revised December 2022. Accessed October 30, 2024.