ZEJULA
Zejula (niraparib tosylate) is a PARP inhibitor indicated for the maintenance treatment of adult patients with advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. It is utilized for patients who have achieved a complete or partial response to platinum-based chemotherapy. For first-line maintenance, the drug is indicated for patients with homologous recombination deficiency (HRD)-positive status, while for recurrent cases, it is indicated for patients with germline BRCA mutations. Treatment selection requires the use of an FDA-approved companion diagnostic to identify appropriate biomarkers.
How ZEJULA Works
Niraparib inhibits PARP-1 and PARP-2 enzymes, which play a critical role in the repair of DNA. The drug's activity involves the inhibition of enzymatic activity and the increased formation of PARP-DNA complexes, resulting in DNA damage and cell death. This cytotoxicity is particularly effective in tumor cells with homologous recombination deficiency or BRCA mutations, where DNA repair pathways are already compromised.
Details
- Status
- Prescription
- First Approved
- 2017-03-27
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
ZEJULA Approval History
What ZEJULA Treats
3 indicationsZEJULA is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZEJULA FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor 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 and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recur...
ZEJULA Patents & Exclusivity
Patents (89 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.