Zejula FDA Approval History
Last updated by Judith Stewart, BPharm on April 30, 2020.
FDA Approved: Yes (First approved March 27, 2017)
Brand name: Zejula
Generic name: niraparib
Dosage form: Capsules
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 recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
- for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:
- a deleterious or suspected deleterious BRCA mutation, or
- genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.
Development timeline for Zejula
Further information
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