Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRCA1 pathogenic variants status confers therapeutic sensitivity to Niraparib in patients with High-Grade Serous Fallopian Tube Cancer.

The U.S. Food and Drug Administration granted approval to niraparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Niraparib's product label states to select patients for therapy based on an FDA-approved companion diagnostic for niraparib.

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

ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.

Citation

GlaxoSmithKline. Zejula (niraparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214876s000lbl.pdf. Revised April 2023. Accessed October 30, 2024. GlaxoSmithKline. Zejula (niraparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214876s000lbl.pdf. Revised April 2023. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-04-26	Food and Drug Administration	Indication received traditional approval.