MorphoSys announced that the US FDA has accepted the company's Biologics License Application and granted priority review for the investigational anti-CD19 antibody for the treatment of relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).
DLBCL, the most common form of non-Hodgkin lymphoma, is an aggressive form of blood cancer with a critical need for additional therapies. MorphoSys' tafasitamab is under review in combination with lenalidomide, and may provide an additional treatment option for patients suffering from DLBCL. Tafasitamab targets the same CD-19 antigen that CAR-T therapies do, but without some of the manufacturing and delivery complexities associated with CAR-T treatments.
If approved, the German-based company's treatment has the potential to rival approved CAR-T therapies from Novartis (Kymriah) and Gilead (Yescarta).
The FDA has set a Prescription Drug User Fee Act goal date of August 30, 2020.
Read the press release
