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Sarclisa FDA Approval History

Last updated by Judith Stewart, BPharm on April 7, 2021.

FDA Approved: Yes (First approved March 2, 2020)
Brand name: Sarclisa
Generic name: isatuximab-irfc
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 with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
  • in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

Development Timeline for Sarclisa

DateArticle
Mar 31, 2021Approval  FDA Approves Sarclisa (isatuximab-irfc) in Combination with Carfilzomib and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma
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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