FDA grants fast track designation to ME-401 for advanced follicular lymphoma
The FDA granted fast track designation to ME-401 for the treatment of adults with relapsed or refractory follicular lymphoma, according to the agent’s manufacturer.
The designation applies to use of ME-401 (MEI Pharma) — a selective oral inhibitor of PI3 kinase-delta — for patients who received at least two prior systemic therapies.
“This designation holds several important advantages to expedite the development and regulatory review of ME-401 as we work diligently to deliver it as a new potential treatment option for patients and their physicians,” Daniel P. Gold, PhD, president and CEO of MEI Pharma, said in a company-issued press release. “We remain very encouraged by the maturing body of ME-401 clinical data, and we are excited to continue expanding the opportunity that ME-401 holds to provide a meaningful impact in the treatment of B-cell malignances.”
MEI Pharma is conducting the phase 2 TIDAL trial to evaluate ME-401 as monotherapy for adults with relapsed or refractory follicular lymphoma after two or more systemic therapies, including chemotherapy and an anti-CD20 antibody.
An open-label, phase 1b dose escalation and expansion trial is evaluating ME-401 as monotherapy and in combination with other therapies for patients with relapsed or refractory B-cell malignancies.