FDA approves Sarclisa for multiple myeloma.- Sanofi
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The European Commission (EC) approved Sarclisa (isatuximab), from Sanofi, in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy.
Oncopeptides AB announced that the Company has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase II HORIZON study in relapsed refractory multiple myeloma.
Karyopharm Therapeutics Inc. announced that the European Commission (EC) has granted conditional marketing authorization for Nexpovio (selinexor), the Company's first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.