31 March 2017 - Kite is preparing for potential approval and launch for axicabtagene ciloleucel in 2017.

Kite Pharma today announced that it has completed the rolling submission with the U.S. FDA of the biologics license application for axicabtagene ciloleucel (previously known as KTE-C19) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant.

"Last month, we announced positive results from our ZUMA-1 pivotal trial with axicabtagene ciloleucel," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "We look forward to working closely with the FDA during the review of axicabtagene ciloleucel and the possibility of bringing this therapy to patients with aggressive NHL whose outlook is dismal with current therapy."

In December 2015 axicabtagene ciloleucel 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 axicabtagene ciloleucel in 2017. Kite is also planning a regulatory submission to the EMA for axicabtagene ciloleucel in 2017.

Read Kite Pharma press release