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.

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