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.