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FDA Grants Priority Review to Kite Pharma’s Axicabtagene Ciloleucel

June 2, 2017

Kite Pharma has received FDA priority review for its axicabtagene ciloleucel biologics license application.

The submission follows positive data demonstrated with a single infusion of axicabtagene ciloleucel in a Phase II clinical trial in patients with refractory aggressive non-Hodgkin lymphoma.

The FDA has set a target action date of Nov. 29.

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