This article is more than 5 years old. Information may no longer be current.
FDA grants fast track designation to fimepinostat for lymphoma subtype
The FDA granted fast track designation to fimepinostat for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who received two or more lines of systemic therapy, according to the agent’s manufacturer.
Fimepinostat (CUDC-907, Curis) is an orally bioavailable inhibitor of both phosphoinositide 3-kinase class I and pan histone deacetylase enzymes, which may prevent growth of tumors that express those enzymes.
The FDA based this designation on phase 1 and phase 2 trials that showed one in four patients with DLBCL with MYC alterations treated with fimepinostat achieved complete or partial response. Median duration of response for all responding patients surpassed 1 year.
“We are pleased with this fast track designation, which will enable us to accelerate the development of fimepinostat for patients with relapsed/refractory DLBCL, including patients whose tumors have MYC alterations,” Ali Fattaey, PhD, CEO of Curis, said in a press release. “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.”
The FDA previously granted fimepinostat orphan drug designation.