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Rydapt for Acute Myeloid Leukemia – Details

Project Number pCODR 10108
Brand Name Rydapt
Generic Name Midostaurin
Tumour Type Leukemia
Indication Acute Myeloid Leukemia
Funding Request In combination with standard induction and consolidation chemotherapy followed by single agent maintenance therapy for adult patients with newly‐diagnosed AML who are FLT3‐mutation positive
Review Status Open for Input on Submission
Pre Noc Submission Yes
NOC Date
Manufacturer Novartis Pharmaceuticals Canada Inc.
Submitter Novartis Pharmaceuticals Canada Inc.
Submission Date June 12, 2017
Submission Type New Drug
Prioritization Requested Requested
Stakeholder Input Deadline ‡ June 26, 2017
Check-point meeting (target date)
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.