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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.
    Select patients for therapy based on an FDA-approved companion diagnostic for Zejula.

Development timeline for Zejula

DateArticle
Apr 29, 2020Approval FDA Approves Zejula (niraparib) as the Only Once-Daily PARP Inhibitor in First-Line Monotherapy Maintenance Treatment for Women with Platinum-Responsive Advanced Ovarian Cancer Regardless of Biomarker Status
Oct 23, 2019Approval FDA Approves Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer
Mar 27, 2017Approval Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer
Dec 20, 2016Tesaro Announces Priority Review Designation for Niraparib NDA
Nov  1, 2016Tesaro Announces Submission of Niraparib NDA For Platinum-sensitive, Recurrent Ovarian Cancer
Sep 12, 2016Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission

See also

Zejula (niraparib) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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