Kite files industry’s first CAR-T marketing authorisation in Europe

Kite files industry’s first CAR-T marketing authorisation in Europe
Credit: Meletios

Kite Pharma has submitted the industry’s first CAR T-cell therapy to the European Medicines Agency.

The marketing application is for Axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma who are ineligible for autologous stem cell transplant.

The application is supported by data from the ZUMA-1 trial, which met the primary endpoint of objective response rate, with 82% of patients achieving a response after a single infusion of axicabtagene ciloleucel.

Non-Hodgkin lymphoma is a type of blood cancer that affects around 93,000 people in Europe every year.

Axicabtagene ciloleucel is currently under review by the US Food and Drug Administration.

In May 2016, the CHMP and CAT granted access to its newly established Priority Medicines regulatory initiative for axicabtagene ciloleucel in the treatment of patients with refractory diffuse large B-cell lymphoma.

Access to the initiative is granted by the EMA to support the development and accelerate the review of new therapies to treat patients with a high unmet need.