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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 Under Review
Pre Noc Submission No
NOC Date August 4, 2016
Manufacturer Takeda Canada Inc.
Submitter Takeda Canada Inc.
Submission Date November 30, 2018
Submission Deemed Complete December 14, 2018
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ December 14, 2018
Check-point meeting February 7, 2019
pERC Meeting April 18, 2019
Initial Recommendation Issued May 3, 2019
Feedback Deadline ‡ May 17, 2019
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.