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Nerlynx for Hormone Receptor-Positive Breast Cancer – Details

Project Number pCODR 10172
Brand Name Nerlynx
Generic Name Neratinib
Tumour Type Breast
Indication Hormone Receptor-Positive Breast Cancer
Funding Request For patients with HER2-positive, hormone receptor-positive breast (HR-positive) cancer who have completed adjuvant trastuzumab-based therapy within the past 12 months
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Knight Therapeutics Inc.
Submitter Knight Therapeutics Inc.
Submission Date April 18, 2019
Submission Deemed Complete May 3, 2019
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ May 3, 2019
Check-point meeting July 4, 2019
pERC Meeting (target date) September 19, 2019
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.