EC Approves Kite’s Tecartus for Relapsed/Refractory Acute Lymphoblastic Leukemia

The European Commission (EC) has granted marketing authorization for Gilead subsidiary Kite’s Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years and older who have relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The company said this approval makes Tecartus the only chimeric antigen receptor (CAR) T-cell indicated for this specific patient population in Europe. It also is approved in the U.S. for this indication.

The authorization follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in July.

The approval is supported by data from a phase 1/2 study that showed a 71 percent complete response rate in heavily treated patients and a median overall survival (OS) rate for all patients of more than two years. According to Gilead, median OS with standard treatment is only about eight months.