First filing for CAR-T therapy in EU

1 August 2017

US cancer drug developer Kite Pharma (Nasdaq: KITE) has become the first company to submit a Marketing Authorization Application (MAA) for a chimeric antigen receptor (CAR) T-cell therapy to the European Medicines Agency (EMA).

The application is for axicabtagene ciloleucel (formerly KTE C19) as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma and primary mediastinal B-cell lymphoma who are ineligible for autologous stem cell transplant.

Axicabtagene ciloleucel is currently under review by the US Food and Drug Administration (FDA), and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 29, 2017.

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