Sarclisa - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

isatuximab

Opinion

On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Sarclisa. The marketing authorisation holder for this medicinal product is Sanofi Winthrop Industrie.

The CHMP adopted a new indication to include treatment of adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

The full indications for Sarclisa will therefore be as follows:¹

Sarclisa is indicated:

• in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
• in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1).
• in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
• in combination with bortezomib, lenalidomide, and dexamethasone, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹ New text in bold

CHMP post-authorisation summary of positive opinion for Sarclisa (II-35)

AdoptedReference Number: EMA/CHMP/186923/2025

Key facts

• Name of medicine:
  Sarclisa
• EMA product number:
  EMEA/H/C/004977
• Active substance:
  Isatuximab
• International non-proprietary name (INN) or common name:
  isatuximab
• Therapeutic area (MeSH):
  Multiple Myeloma
• Anatomical therapeutical chemical (ATC) code:
  L01XC38
• Marketing authorisation holder:
  Sanofi Winthrop Industrie
• Date of opinion:
  19/06/2025
• Status:
  Positive