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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 Notification to Implement Issued
Pre Noc Submission No
NOC Date June 27, 2019
Manufacturer GlaxoSmithKline Inc.
Sponsor GlaxoSmithKline Inc.
Submission Date February 7, 2020
Submission Deemed Complete February 24, 2020
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ February 24, 2020
Check-point meeting April 8, 2020
pERC Meeting June 18, 2020
Initial Recommendation Issued July 3, 2020
Feedback Deadline ‡ July 17, 2020
pERC Reconsideration Meeting August 20, 2020
Final Recommendation Issued September 3, 2020
Notification to Implement Issued September 21, 2020

‡ 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.