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Isatuximab (Sarclisa) for Multiple Myeloma - Details

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 (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.