Biopharmaceutical company Incyte Corp. (INCY) and German peer MorphoSys AG (MOR,MPSYY.PK) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).
The positive opinion from the CHMP is based on data from the Phase 2 L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL.
The CHMP opinion to recommend the use of tafasitamab is now being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union (EU).
If approved, tafasitamab in combination with lenalidomide would represent an important new therapeutic option for eligible DLBCL patients in the European Union. It would be commercialized in the EU under the brand name Minjuvi.
DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide comprising 40% of all cases and characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs.
Incyte and MorphoSys share global development rights to tafasitamab and Incyte has exclusive commercialization rights to tafasitamab outside the United States.
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