Sarclisa

isatuximab

Opinion

On 26 March 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Sarclisa1, intended for the treatment of multiple myeloma. The applicant for this medicinal product is sanofi-aventis groupe.

Sarclisa will be available as 20 mg/ml concentrate for solution for infusion. The active substance of Sarclisa is isatuximab, an IgG1-derived monoclonal antibody (ATC code: L01XC38) that binds to a specific extracellular epitope of CD38 receptor resulting in cancer cell death. CD38 is a transmembrane glycoprotein that is highly expressed on multiple myeloma cells.

The benefits with Sarclisa are its ability to improve progression free survival (PFS) represented by a 40.4% reduction in the risk of disease progression or death. The most common side effects are neutropenia), infusion reactions, pneumonia, upper respiratory tract infection, diarrhoea and bronchitis.

The full indication is:

“Sarclisa is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.”

Sarclisa should be administered by a healthcare professional, in an environment where resuscitation facilities are available.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

Key facts

Name
Sarclisa
Agency product number
EMEA/H/C/004977
International non-proprietary name (INN) or common name
  • isatuximab
Active substance
  • Isatuximab
Therapeutic area
Multiple Myeloma
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
26/03/2020
Company name
sanofi-aventis groupe 
Status
Positive
Application type
Initial authorisation

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