Zejula (niraparib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

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.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	BRCA1 pathogenic variants	Ovarian Epithelial Tumor	Niraparib
FDA (1)	BRCA2 pathogenic variants	Ovarian Epithelial Tumor	Niraparib
FDA (1)	BRCA1 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Niraparib
FDA (1)	BRCA2 pathogenic variants	High-Grade Serous Fallopian Tube Cancer	Niraparib
FDA (1)	BRCA1 pathogenic variants	Peritoneal Serous Carcinoma	Niraparib
FDA (1)	BRCA2 pathogenic variants	Peritoneal Serous Carcinoma	Niraparib