Kite Pharma, Inc, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for the company’s lead investigational therapy, an autologous engineered T-cell product that targets CD19 expression on B-cell malignancies, for the treatment of diffuse large B-cell lymphoma.
Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States. The orphan drug designation also would entitle Kite Pharma to a 7-year period of marketing exclusivity in the United States. ■
