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Sarclisa FDA Approval History

FDA Approved: Yes (First approved March 2, 2020)
Brand name: Sarclisa
Generic name: isatuximab-irfc
Previous name: isatuximab
Dosage form: Injection
Company: Sanofi
Treatment for: Multiple Myeloma

Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients multiple myeloma.

Development Timeline for Sarclisa

Mar  2, 2020Approval  FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma
Jul 10, 2019FDA to Review Isatuximab as a Potential Treatment for Relapsed/Refractory Multiple Myeloma
Jun  2, 2019Phase 3 Trial of Isatuximab Combination Therapy Showed 40% Reduction in the Risk of Disease Progression or Death for Patients with Relapsed/Refractory Multiple Myeloma

Further information

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