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FDA Grants Priority Review to KTE-C19 for Non-Hodgkin Lymphoma

Silas Inman @silasinman
Published: Friday, May 26, 2017

Dr David Chang

David Chang, MD, PhD

The FDA has granted a priority review to axicabtagene ciloleucel (KTE-C19; axi-cel) for transplant-ineligible patients with relapsed or refractory non-Hodgkin lymphoma (NHL), according to Kite Pharma, the developer of the CD19-directed chimeric antigen receptor (CAR) T-cell therapy.

The most common grade ≥3 adverse events (AEs) were anemia (43%), neutropenia (39%), decreased neutrophil count (32%), febrile neutropenia (31%), decreased white blood cell count (29%), thrombocytopenia (24%), encephalopathy (21%), and decreased lymphocyte count (20%).

At the primary analysis of 101 patients, the rate of cytokine release syndrome (CRS) dropped to 13% versus 18% at the interim assessment, which included 93 patients. Additionally, neurologic events dropped from 34% in the interim analysis to 28% in the primary assessment. Overall, 43% of patients received tocilizumab and 27% received corticosteroids to resolve CRS.

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