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Gilteritinib (Xospata) for Acute Myeloid Leukemia - Details

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.