Pharmaceutical Business review

Allos Therapeutics wins FDA orphan drug designation for lymphoma drug

Pralatrexate is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase, a folic acid-dependent enzyme involved in the building of nucleic acid, or DNA, and other processes. The company believes pralatrexate has the potential to be delivered as a single agent or in combination therapy regimens.

Paul Berns, president and CEO of Allos, said: “We are pleased that the FDA has recognized the unmet medical need for effective new therapies for the treatment of patients with follicular lymphoma. This designation further complements the orphan drug designation that the FDA previously awarded to pralatrexate in patients with T-cell lymphoma and diffuse large B-cell lymphoma.”