Zejula FDA Approval History
Last updated by Judith Stewart, BPharm on July 3, 2023.
FDA Approved: Yes (First approved March 27, 2017)
Brand name: Zejula
Generic name: niraparib
Dosage form: Capsules and Tablets
Company: GlaxoSmithKline
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Zejula (niraparib) is an oral, poly ADP-ribose polymerase (PARP) inhibitor for the treatment of patients with ovarian, fallopian tube, or primary peritoneal cancer.
- Zejula is indicated:
- for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
- 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 a complete or partial response to platinum-based chemotherapy.
Select patients for therapy based on an FDA-approved companion diagnostic for Zejula.
Development timeline for Zejula
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
