Posted by Michael Wonder on 27 Oct 2017
MorphoSys receives FDA breakthrough therapy designation for its antibody MOR208 in relapsed/refractory DLBCL
23 October 2017 - Designation is intended to expedite development of MorphoSys's most advanced blood cancer drug candidate MOR208 in combination with cancer drug lenalidomide.
MorphoSys announced today that the U.S. FDA has granted breakthrough therapy designation to MOR208, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for high-dose chemotherapy and autologous stem-cell transplantation. MOR208 is an investigational Fc-engineered monoclonal antibody directed against CD19 which is currently in clinical development in blood cancer indications.
FDA breakthrough therapy designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs. It is granted if preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over existing therapies in the treatment of a serious or life-threatening disease.
