On November 7, 2014 MorphoSys reported that the Food & Drug Administration (FDA) has granted fast track designation to MOR208, MorphoSys’s humanized Fc engineered monoclonal antibody against CD19, for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release MorphoSys, NOV 7, 2014, View Source [SID:1234500937]). The FDA’s fast track program aims to expedite the development and review of drugs that have the potential to fill an unmet medical need in serious or life-threatening conditions.

“First results of our ongoing Phase 2 trial, which we will present at this year’s ASH (Free ASH Whitepaper) conference in December, have helped to identify diffuse large B-cell lymphoma as a valuable development opportunity for MOR208. We are therefore delighted to have received the fast track designation for further development of MOR208 in DLBCL. The more frequent interactions with the FDA that this enables will help us to expedite the development of MOR208 in this particular subset of non-Hodgkin’s lymphoma patients,” commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

DLBCL is the most common lymphoma and accounts for approximately 25 percent of all NHLs in the developed world. The disease occurs primarily in older individuals, though it can also occur in children and young adults in rare cases.

MOR208 is a humanized monoclonal antibody targeting the antigen CD19, which is being developed for the treatment of B-cell malignancies. The program is currently in phase 2 clinical development in chronic lymphocytic leukemia (CLL), acute lymphoblastic B-cell leukemia (B-ALL) and non-Hodgkin’s lymphoma (NHL). MOR208 was in-licensed from Xencor Inc. in 2010.