| Project Number | pCODR 10108 |
|---|---|
| Brand Name | Rydapt |
| Generic Name | Midostaurin |
| Strength | 25 mg |
| Tumour Type | Leukemia |
| Indication | Acute Myeloid Leukemia |
| Funding Request | In combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML) |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | July 21, 2017 |
| Manufacturer | Novartis Pharmaceuticals Canada Inc. |
| Sponsor | Novartis Pharmaceuticals Canada Inc. |
| Submission Date | June 12, 2017 |
| Submission Deemed Complete | June 19, 2017 |
| Submission Type | New Drug |
| Prioritization Requested | Requested and Granted |
| Stakeholder Input Deadline ‡ | June 26, 2017 |
| Check-point meeting | September 26, 2017 |
| pERC Meeting | November 16, 2017 |
| Clarification | The timeline of the review was temporarily stopped as of July 27, pending receipt of updated economic information from the submitter. The documents were received, and the submission resumed on August 17. |
| Initial Recommendation Issued | November 30, 2017 |
| Feedback Deadline ‡ | December 14, 2017 |
| Final Recommendation Issued | December 19, 2017 |
| Notification to Implement Issued | January 11, 2018 |
‡ 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.
