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Niraparib (Zejula) for first line Ovarian Cancer - Details

Project Number PC0224-000
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 Initial
Prioritization Requested
Stakeholder Input Deadline ‡ October 5, 2020
Check-point meeting November 26, 2020
pERC Meeting February 18, 2021
Initial Recommendation Issued March 4, 2021
Feedback Deadline ‡ March 18, 2021
pERC Reconsideration Meeting (target date) April 15, 2021
Final Recommendation Issued (target date) April 29, 2021
Notification to Implement Issued
Therapeutic Area First Line OC

‡ 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.