The U.S. Food and Drug Administration granted fast-track status to MEI Pharma Inc.'s drug ME-401 to treat patients with a type of blood cancer.
The designation was given to ME-401 to treat patients with relapsed or refractory follicular lymphoma that has not improved after receiving at least two prior lines of systemic therapy.
Follicular lymphoma is a type of cancer that develops when the body makes abnormal versions of white blood cells called B lymphocytes, or B cells, which help protect the body against bacteria or viruses by making proteins called antibodies.
San Diego, Calif.-based MEI Pharma is evaluating ME-401 as a stand-alone therapy in a phase 2 trial, dubbed Tidal, in patients with this indication. The company plans to use this study to support its request to the U.S. regulator for accelerated approval.
The FDA grants fast-track designation to products that can address an unmet medical need, with benefits including eligibility for a rolling submission of a drug and the possibility of an expedited review.