BRIEF—Gilead seeks broader Tecartus label in Europe

The European Medicines Agency has begun reviewing a submission from Kite, a Gilead Sciences company, to broaden the label for Tecartus (brexucabtagene autoleucel) to include relapsed or refractory B cell precursor acute lymphoblastic leukaemia (aALL).

The treatment was approved as an option for mantle cell lymphoma in the USA and in Europe in 2020.

The submission is backed by data from the Phase III ZUMA-3 trial, detailed results from which were published in The Lancet.

Kite’s Dick Sundh, head of Australia, Canada and Europe, said: “We are working closely with the regulatory authorities to progress our application to potentially bring the benefits of CAR T cell therapy to adult patients in Europe, with anticipated approval in 2022.”