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FDA Grants Fast Track Designation to PI3K Inhibitor ME-401 for Patients with FL

The FDA granted fast track designation to ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies, according to MEI Pharma, the agent’s developer.1

The company is currently conducting TIDAL (Trials of PI3K Delta in Hon-Hodgkin’s Lymphoma), which is a phase II trial assessing ME-401 in patients with relapsed or refractory lymphoma after failure of at least 2 prior systemic therapies, including chemotherapy and an anti-CD20 antibody. 

“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 chief…

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