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| Project Number | pCODR 10220 |
|---|---|
| Brand Name | Sarclisa |
| Generic Name | Isatuximab |
| Strength | 100mg and 500mg |
| Tumour Type | Myeloma |
| Indication | Multiple Myeloma |
| Funding Request | Isatuximab in combination with pomalidomide and dexamethasone, for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. |
| Review Status | Under Review |
| Pre Noc Submission | No |
| NOC Date | April 29, 2020 |
| Manufacturer | Sanofi Genzyme |
| Sponsor | Sanofi Genzyme |
| Submission Date | August 17, 2020 |
| Submission Deemed Complete | August 31, 2020 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | August 31, 2020 |
| Check-point meeting | October 28, 2020 |
| pERC Meeting | January 21, 2021 |
| Initial Recommendation Issued (target date) | February 4, 2021 |
| Feedback Deadline (target date) ‡ | February 19, 2021 |
| 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.