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MEI Pharma's blood cancer drug gets US FDA fast-track tag

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.