Nerlynx for Hormone Receptor-Positive Breast Cancer – Details

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Generic Name:
Neratinib
Project Status:
Complete
Therapeutic Area:
ERBB2-positive breast cancer
Manufacturer:
Knight Therapeutics Inc.
Brand Name:
Nerlynx
Project Line:
Reimbursement Review
Project Number:
PC0172-000
NOC Status at Filing:
Pre NOC
Strength:
40 mg
Tumour Type:
Breast
Indications:
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
Pre Noc Submission:
Yes
Sponsor:
Knight Therapeutics Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Do not reimburse
pERC Meeting:
Final Recommendation 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.