EMA begins review of Morpho Sys CD19 monoastytasitamab to treat lymphoma

The European Medicines Agency (EMA) has begun a review of MorphoSys targeting CD19's monophonoid tafasitamab (MOR208), which, if approved, could pose a challenge to Novartis and Gilead's CAR-T therapyU.Sregulators accepted a marketing application from MorphoSus and its partner Incyte's tafasitamab to treat adult patients with recurrent or incurable diffuse large B-cell lymphoma (DLBCL) who are not suitable for stem cell transplantationPhase 2 L-MIND results showed that the overall remission rate was 60 percent, including 43 percent, in patients who combined tafasitamab with Celgene's RevlimidNovartis' Kymriah and Gilead's Yescarta (axicabagene cilolecel) CAR-T therapy, high doses of chemotherapy were needed, and many patients, especially the elderly, were not physically strong enough to tolerate the treatmentDLBCL is the most common non-Hodgkin's lymphoma (NHL) among adults worldwide, accounting for 40 percent of all cases, and is a very aggressive disease -- about 30-40% of patients do not respond to initial treatment or relapse, which means an urgent need for new treatments