Sarclisa - opinion on variation to marketing authorisation

Opinion

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

isatuximab

Opinion

On 26 March 2026, 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 route of administration, subcutaneous, along with a new pharmaceutical form, solution for injection, and a new strength of 1400 mg.

For information, the full indications for Sarclisa will remain as follows:

Isatuximab 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.

CHMP post-authorisation summary of positive opinion for Sarclisa (X/0000281242)

Adopted Reference Number: EMADOC-1700519818-3026808

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:
  26/03/2026
• Status:
  Positive