| 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 |
| Sponsor | 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.
