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Ninlaro for Multiple Myeloma (2nd-beyond) – Details

Project Number pCODR 10164
Brand Name Ninlaro
Generic Name Ixazomib
Strength 4 mg, 3 mg and 2.3 mg
Tumour Type Myeloma
Indication Multiple Myeloma (2nd-beyond)
Funding Request In combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
Review Status Pending
Pre Noc Submission No
NOC Date August 4, 2016
Manufacturer Takeda Canada Inc.
Submitter Takeda Canada Inc.
Submission Date (Target Date) November 30, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ December 14, 2018
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.