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Midostaurin (Rydapt) for Systemic Mastocytosis

Project Number pCODR 10193
Brand Name Rydapt
Generic Name Midostaurin
Strength 25 mg
Tumour Type Other
Indication Systemic Mastocytosis
Funding Request For the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
Review Status Under Review
Pre Noc Submission No
NOC Date October 3, 2018
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date August 13, 2019
Submission Deemed Complete August 27, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ August 27, 2019
Check-point meeting October 16, 2019
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.