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Niraparib (Zejula) for Ovarian Cancer - Details

Project Number pCODR 10203
Brand Name Zejula
Generic Name Niraparib
Strength 100 mg
Tumour Type Gynecology
Indication Ovarian Cancer
Funding Request As monotherapy for the maintenance treatment of female adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Review Status Open for Input on Submission
Pre Noc Submission No
NOC Date June 27, 2019
Manufacturer GlaxoSmithKline Inc.
Sponsor GlaxoSmithKline Inc.
Submission Date February 7, 2020
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ February 24, 2020
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.