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Isatuximab plus pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma

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2 Information about isatuximab

Anticipated marketing authorisation indication

2.1 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 isatuximab (Sarclisa, Sanofi) 'in combination with pomalidomide and dexamethasone, indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy'.

Dosage in the marketing authorisation

2.2 The dosage schedule will be available in the summary of product characteristics.

Price

2.3 The list price for isatuximab will be available after the marketing authorisation has been received. The company has a commercial arrangement, which would have applied if the technology had been recommended.