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Rydapt for Acute Myeloid Leukemia – Details

Project Number pCODR 10108
Brand Name Rydapt
Generic Name Midostaurin
Strength 25 mg
Tumour Type Leukemia
Indication Acute Myeloid Leukemia
Funding Request In combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML)
Review Status Open for Feedback on Recommendation
Pre Noc Submission Yes
NOC Date July 21, 2017
Manufacturer Novartis Pharmaceuticals Canada Inc.
Submitter Novartis Pharmaceuticals Canada Inc.
Submission Date June 12, 2017
Submission Deemed Complete June 19, 2017
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ June 26, 2017
Check-point meeting September 26, 2017
pERC Meeting November 16, 2017
Clarification The timeline of the review was temporarily stopped as of July 27, pending receipt of updated economic information from the submitter. The documents were received, and the submission resumed on August 17.
Initial Recommendation Issued November 30, 2017
Feedback Deadline (target date) ‡ December 14, 2017
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.