Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Niraparib
FDA (2)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Niraparib
FDA (2)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Niraparib
FDA (2)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Niraparib
FDA (2)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Niraparib
FDA (2)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Niraparib

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.