MorphoSys : EU Conditionally Approves Minjuvi - Lenalidomide To Treat Relapsed Or Refractory DLBCL

(RTTNews) - The European Commission has granted conditional marketing authorization for Minjuvi or tafasitamab in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma or DLBCL who are not eligible for autologous stem cell transplant or ASCT, MorphoSys AG (MOR) and Incyte (INCY) said in a statement.

The conditional approval was based on the results from the L-MIND study evaluating the safety and efficacy of tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT).

The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee.

Incyte and MorphoSys share global development rights to tafasitamab. Incyte has exclusive commercialization rights to tafasitamab outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and is marketed by Incyte under the brand name Minjuvi in the EU.