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Niraparib (Zejula) for first line Ovarian Cancer - Details

Project Number pCODR 10224
Brand Name Zejula
Generic Name Niraparib
Strength 100 mg
Tumour Type Gynecology
Indication Ovarian Cancer
Funding Request 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
Review Status Under Review
Pre Noc Submission Yes
NOC Date October 2, 2020
Manufacturer GlaxoSmithKline Inc.
Sponsor GlaxoSmithKline Inc.
Submission Date September 21, 2020
Submission Deemed Complete October 5, 2020
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ October 5, 2020
Check-point meeting November 26, 2020
pERC Meeting (target date) February 18, 2021
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.