| Project Number | pCODR 10172 |
|---|---|
| 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 | Under Review |
| 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 | New Drug |
| 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 (target date) | November 21, 2019 |
| 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.
