FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Grants Priority Review to Kite Pharma’s Axicabtagene Ciloleucel

June 2, 2017
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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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