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Gilteritinib (Xospata) for Acute Myeloid Leukemia - Details

Project Number pCODR 10202
Brand Name Xospata
Generic Name Gilteritinib
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 Under Review
Pre Noc Submission Yes
NOC Date
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 (target date) January 29, 2020
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.