Curis announces FDA fast track designation for fimepinostat (CUDC-907) development in patients with relapsed or refractory diffuse large B-cell lymphoma

Curis

31 May 2018 - Curis announced today that the U.S. FDA has granted fast track designation for the development of fimepinostat (formerly CUDC-907) in adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. 

Previously reported results from Phase 1 and Phase 2 clinical studies demonstrated that treatment with fimepinostat resulted in a complete or partial response in approximately one out of every four patients with relapsed or refractory diffuse large B-cell lymphoma with MYC alterations. The median duration of response for all responding patients in these studies was over one year.

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track