Curis $CRIS said the US Food and Drug Administration (FDA) granted Fast Track designation for the development of its drug 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.
In previous phase II and phase II clinical studies, fimepinostat demonstrated it could produce a complete or partial response in approximately one out of every four patients with R/R DLBCL with MYC alterations, according to Curis. The median duration of response for all responding patients in these studies was more than one year.
Because of the Fast Track designation, Curis said it is coordinating new efforts with commercial product manufacturers as well as the development of a potential diagnostic test for the targeted patient group.
The FDA Fast Track process is intended to facilitate the development and expedite review of drugs used to treat serious conditions and fill an unmet medical need. The designation provides Curis with more frequent meetings and written communications with the FDA regarding fimepinostat’s development plan, trial design and data collection to support the drug’s approval. Fast Track designation also provides eligibility for Accelerated Approval and Priority Review.