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Thursday, May 31, 2018

Curis gets FDA fast track for lymphoma med


Curis announced that the U.S. FDA has granted fast track designation for the development of fimepinostat in patients with relapsed or refractory, or R/R, diffuse large B-cell lymphoma, or 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 one out of every four patients with R/R DLBCL with MYC alterations. The median duration of response for all responding patients in these studies was over one year.

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