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Ninlaro for Multiple Myeloma – Details

Project Number pCODR 10088
Brand Name Ninlaro
Generic Name Ixazomib
Strength 4 mg, 3 mg, and 2.3 mg capsules
Tumour Type Myeloma
Indication Multiple Myeloma
Funding Request Adult patients with multiple myeloma who have received at least one prior therapy and have high-risk cytogenetics, or have received at least two prior therapies
Review Status Notification to Implement Issued
Pre Noc Submission No
NOC Date August 4, 2016
Manufacturer Takeda Pharmaceutical Company Limited
Submitter Takeda Pharmaceutical Company Limited
Submission Date December 16, 2016
Submission Deemed Complete January 20, 2017
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ January 9, 2017
Check-point meeting February 22, 2017
pERC Meeting April 20, 2017
Initial Recommendation Issued May 4, 2017
Feedback Deadline ‡ May 18, 2017
pERC Reconsideration Meeting June 16, 2017
Clarification Please note that the June pERC meeting was conducted over two days. The target for the posting of pERC Initial Recommendation remains as June 29, 2017.
Final Recommendation Issued June 29, 2017
Notification to Implement Issued July 17, 2017

‡ 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.