Sarclisa (isatuximab) PDUFA Date (Sanofi)

Name: FDA PDUFA Decision: Sarclisa (isatuximab)
Start: 2026-04-23

FDA PDUFA decision date for Sarclisa (isatuximab) is April 23, 2026. Developed by Sanofi. Indication: Multiple myeloma (new combination/setting). Current status: Approved.

Indication

Multiple myeloma (new combination/setting)

Regulatory details

Company: Sanofi
Therapeutic area: Oncology
Application type: sBLA
Review type: Standard
PDUFA date: 2026-04-23
Outcome: Approved

Sarclisa (isatuximab) PDUFA Date — Sanofi