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| Project Number | pCODR 10220 |
|---|---|
| Brand Name | Sarclisa |
| Generic Name | Isatuximab |
| 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 | Pending |
| Pre Noc Submission | No |
| NOC Date | |
| Manufacturer | Sanofi Genzyme |
| Sponsor | Sanofi Genzyme |
| Submission Date (Target Date) | August 17, 2020 |
| Submission Type | New Drug |
| Prioritization Requested | |
| Stakeholder Input Deadline (target date based on target submission date) ‡ | August 31, 2020 |
| 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.
