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CHMP recommends approval of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of recurrent multiple myeloma

 Last Update: 2021-03-20
 Source: Internet
 Author: User

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Recently, the European Medicines Management Agency (EMA) Committee for Medicinal suggested use (CHMP) approved Sarclisa (isatuximab) and carfilzomib and dexamethasone (Kd) used in combination relapsed multiple myeloma (MM), these patients previously Have received at least one therapy.

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Peter Adamson, Global Development Director of Sanofi Oncology and Pediatric Innovation, said: "The combination of Sarclisa with two standard care programs has shown excellent results.

Sarclisa is currently approved in Europe for use in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed and refractory MM who have received at least two previous therapies (including lenalidomide and proteasome inhibitors).

The positive opinion of CHMP is based on data from the IKEMA Phase III study, which is a randomized, multi-center, open-label clinical trial involving 302 MM patients from 16 countries.

Compared with Kd alone, Sarclisa combined with Kd reduced the patient’s risk of disease progression or death by 47%.

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