MEI Pharma’s (NASDAQ:MEIP) ME-401 received FDA fast track designation for the treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.
The company is currently conducting a Phase 2 trial intended to support an accelerated approval marketing application with the FDA.
“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 Gold, MEI Pharma’s president and CEO, said in a statement.
“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 malignancies,” he added.
