27 March 2020 - Positive CHMP opinion based on data from ICARIA-MM, the first randomised Phase 3 trial to evaluate an anti-CD38 in combination with pomalidomide and dexamethasone.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa (isatuximab).
The CHMP recommends Sarclisa 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.