Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma

Sanofi

27 May 2024 - FDA priority review granted based on positive results from IMROZ Phase 3 study.

The US FDA has accepted for priority review the supplemental biologics license application for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma.

Read Sanofi press release


Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier