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Isatuximab (Sarclisa) for Multiple Myeloma - Details

Project Number PC0220-000
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 Notification to Implement Issued
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 Initial
Prioritization Requested
Stakeholder Input Deadline ‡ August 31, 2020
Check-point meeting October 28, 2020
pERC Meeting January 21, 2021
Initial Recommendation Issued February 4, 2021
Feedback Deadline ‡ February 19, 2021
pERC Reconsideration Meeting March 18, 2021
Final Recommendation Issued April 1, 2021
Notification to Implement Issued April 19, 2021
Therapeutic Area Multiple Myeloma

‡ 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.