CADTH | Evidence Driven
CADTH | Evidence Driven

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
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.
Review Status:
Complete
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:

Files

Provincial Funding Summary View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – pERC Final Recommendation Final Recommendation May 20, 2020 View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – Final Clinical Guidance Report Guidance Reports May 20, 2020 View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – Final Economic Guidance Report Guidance Reports May 20, 2020 View PDF
Gilteritinib (Xospata) AML – pERC Initial Recommendation Initial Recommendation April 30, 2020 View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – PAG Feedback on Initial Recommendation Feedback May 20, 2020 View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – Submitter Feedback on Initial Recommendation Feedback May 20, 2020 View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – Patient Feedback on Initial Recommendation Feedback May 20, 2020 View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – Clinician Feedback on Initial Recommendation Feedback May 20, 2020 View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – Patient COI Declarations COI Declarations May 20, 2020 View PDF
Gilteritinib (Xospata) for Acute Myeloid Leukemia – Clinician COI Declarations COI Declarations May 20, 2020 View PDF

‡ 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.

Last Updated : June 4, 2020