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FDA Grants Curis Fast Track Designation

For fimepinostat (formerly CUDC-907) in adult patients with relapsed or refractory diffuse large B-cell lymphoma

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of Curis’ fimepinostat (formerly CUDC-907) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) 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 R/R D...

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