FDA Fast Tracks Morphosys Monoclonal Antibody Against CD19

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Biopharmaceutical company MorphoSys is reporting that it has been given fast track designation from the US Food and Drug Administration (FDA) for MOR208 to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

MOR208 is a humanized monoclonal antibody against the cell surface protein CD19. It is being developed by the company for the treatment of B-cell lymphomas.

"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," says MorphoSys chief development officer Dr. Arndt Schottelius. "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 investigational compound is currently being tested in Phase II clinical trials against chronic lymphocytic leukemia (CLL), acute lymphoblastic B-cell leukemia (B-ALL) and non-Hodgkin's lymphoma (NHL).

Source: Morphosys

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