| Project Number | pCODR 10108 |
|---|---|
| Brand Name | Rydapt |
| Generic Name | Midostaurin |
| Tumour Type | Leukemia |
| Indication | Acute Myeloid Leukemia |
| Funding Request | In combination with standard induction and consolidation chemotherapy followed by single agent maintenance therapy for adult patients with newly‐diagnosed AML who are FLT3‐mutation positive |
| Review Status | Open for Input on Submission |
| Pre Noc Submission | Yes |
| NOC Date | |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Submitter | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | June 12, 2017 |
| Submission Type | New Drug |
| Prioritization Requested | Requested |
| Stakeholder Input Deadline ‡ | June 26, 2017 |
| Check-point meeting (target date) | |
| pERC Meeting (target date) | |
| 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.