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news.MorphoSys has received fast track designation from the US Food and Drug Administration (FDA) for MOR208 to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a most common lymphoma.
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DLBCL accounts for about 25% of all NHLs in the developed world and it occurs primarily in older individuals, while the disease can also occur in children and young adults in rare cases.
MOR208 is a humanized monoclonal antibody against CD19 and is being developed for the treatment of B-cell malignancies.
MorphoSys chief development officer Dr Arndt Schottelius said: "First results of our ongoing Phase II trial, which we will present at this year’s ASH conference in December, have helped to identify diffuse large B-cell lymphoma as a valuable development opportunity for MOR208.
"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."
The FDA fast track program aims to expedite the development and review of drugs that have the potential to fill an unmet medical need.
MOR208 is currently in Phase II clinical development in chronic lymphocytic leukemia (CLL), acute lymphoblastic B-cell leukemia (B-ALL) and non-Hodgkin’s lymphoma (NHL).