Adhoc: MorphoSys Receives FDA Breakthrough Therapy Designation for Its Antibody MOR208 in Relapsed/Refractory DLBCL
Designation is intended to expedite development of MorphoSys's most advanced blood cancer drug candidate MOR208 in combination with cancer drug lenalidomide
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to MOR208, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) 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.
FDA's Breakthrough Therapy designation is based on preliminary data from the ongoing phase 2 L-MIND study (NCT02399085), which is evaluating the safety and efficacy of MOR208 in combination with lenalidomide in patients with R/R DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplantation.
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