Gilteritinib (Xospata) for Acute Myeloid Leukemia - Details

Details

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Generic Name:
Gilteritinib
Project Status:
Complete
Manufacturer:
Astellas Pharma Canada Inc.
Brand Name:
Xospata
Project Line:
Reimbursement Review
Project Number:
PC0202 -000
Performance Metric:
Achieved
Strength:
40mg
Tumour Type:
Leukemia
Indications:
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.
Pre Noc Submission:
Yes
Sponsor:
Astellas Pharma Canada 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:
Reimburse with clinical criteria and/or conditions
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.