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Nerlynx for Hormone Receptor-Positive Breast Cancer – Details

Project Number PC0172-000
Brand Name Nerlynx
Generic Name Neratinib
Strength 40 mg
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 Complete
Pre Noc Submission Yes
NOC Date July 16, 2019
Manufacturer Knight Therapeutics Inc.
Sponsor Knight Therapeutics Inc.
Submission Date April 18, 2019
Submission Deemed Complete May 3, 2019
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ May 3, 2019
Check-point meeting July 4, 2019
pERC Meeting September 19, 2019
Initial Recommendation Issued October 3, 2019
Feedback Deadline ‡ October 18, 2019
pERC Reconsideration Meeting November 21, 2019
Final Recommendation Issued December 5, 2019
Notification to Implement Issued December 20, 2019
Therapeutic Area ERBB2-positive breast cancer
Recommendation Type Do not reimburse

‡ 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.