Curis announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of 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 DLBCL with MYC alterations. The median duration of response for all responding patients in these studies was over one year.
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"We are pleased with this Fast Track designation, which will enable us to accelerate the development of fimepinostat for patients with R/R DLBCL, including patients whose tumors have MYC alterations," said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "Patients with this disease have a very poor prognosis and we are encouraged by the FDA's recognition of the unmet need that may be addressed by fimepinostat, as well as the potential durable benefit that fimepinostat can provide for these patients. We expect to re-initiate enrollment this year as part of a pivotal study to assess fimepinostat's efficacy in this patient population. As we work toward the start of this study, we are also continuing to lay the groundwork for potential registration of fimepinostat, which involves coordination with commercial product manufacturers as well as a potential diagnostic test."
The FDA Fast Track process is designed to facilitate the development and expedite review of drugs used to treat serious conditions and fill an unmet medical need. Fast Track 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, if the relevant criteria are met, as well as Rolling Review with regards to the submission of the completed sections of the NDA for review by the FDA.