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FDA grants orphan drug status to anti-CD19 T cell immunotherapy for DLBCL

Kite Pharma, Inc. today announced that the FDA granted orphan drug designation for its autologous engineered T-cell product that targets CD19 expression on B-cell malignancies for the treatment of diffuse large B-cell lymphoma.

Although most patients with diffuse large B-cell lymphoma (DLBCL) can be cured by either chemotherapy or transplant, a significant proportion of patients have disease that is resistant to chemotherapy.  For these patients, there is a substantial unmet need for more effective therapies.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to novel drugs and biologics that are 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 would permit Kite Pharma to a 7-year period of marketing exclusivity in the United States pending FDA approval of Kite's product for the treatment of DLBCL.