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| Project Number | pCODR 10202 |
|---|---|
| Brand Name | Xospata |
| Generic Name | Gilteritinib |
| Strength | 40mg |
| Tumour Type | Leukemia |
| Indication | Acute Myeloid Leukemia (AML) |
| Funding Request | For the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by a validated test. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | December 23, 2019 |
| Manufacturer | Astellas Pharma Canada Inc. |
| Sponsor | Astellas Pharma Canada Inc. |
| Submission Date | October 28, 2019 |
| Submission Deemed Complete | November 11, 2019 |
| Submission Type | New Indication |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | November 11, 2019 |
| Check-point meeting | January 29, 2020 |
| pERC Meeting | April 16, 2020 |
| Initial Recommendation Issued | April 30, 2020 |
| Feedback Deadline ‡ | May 14, 2020 |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued | May 20, 2020 |
| Notification to Implement Issued | June 4, 2020 |
‡ 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.
