Niraparib

Details

Generic Name:

Niraparib

Project Status:

Complete

Therapeutic Area:

First Line OC

Manufacturer:

GlaxoSmithKline Inc.

Brand Name:

Zejula

Project Line:

Reimbursement Review

Project Number:

PC0224-000

Tumour Type:

Gynecology

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

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.

Submission Type:

Initial

Fee Schedule:

Pending

Indications:

First-Line Maintenance Treatment of Advanced Ovarian 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.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Last Updated : June 18, 2025