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Kite submits US FDA application for lymphoma drug

Kite Pharma Inc. completed the rolling submission with the U.S. FDA for its biologics license application for axicabtagene ciloleucel, a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant.

The company reported positive results from a drug trial in February.

Kite Pharma received breakthrough therapy designation by the FDA for diffuse large B-cell lymphoma, transformed follicular lymphoma and primary mediastinal B-cell lymphoma.

If approved, Kite plans to commercially launch the drug in 2017. It also plans a regulatory submission to the European Medicines Agency for axicabtagene ciloleucel in 2017.