Gilead's CAR T therapy Tecartus authorised in EU for MCL

Gilead’s Kite division has announced that its chimericantigen receptor (CAR) T cell therapy Tecartus has received conditional marketing authorisation for the treatment of relapsed or refractory mantle cell lymphoma  (MCL).

The conditional marketing authorisation covers patients who have already received two or more lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

Patients with relapsed or refractory MCL, pre-treated with two or more lines of systemic therapy including a BTK inhibitor, often have a poor prognosis – with a median overall survival of six to 12.5 months.

In the phase II ZUMA-2 trial, an overall response rate (including complete or partial) was observed in 93% of 60 patients treated with Tecartus, with 67% of those patients achieving a complete response.

“Kite is committed to bringing the potential of CAR T cell therapy to patients with haematological cancers, and as such, we are proud that our second cell therapy has been granted conditional marketing authorisation in Europe,” said Ken Takeshita, global head of clinical development.

“I extend my thanks to the patient study participants, carers, clinical researchers, regulators and dedicated colleagues at Kite who helped make this possible,” he added.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) initially backed conditional marketing authorisation for Tecartus for the treatment of adult patients with mantle cell lymphoma in its October 2020 meeting.

Tecartus benefited from the EMA’s PRIME scheme, which is the agency’s platform for early and enhanced dialogue with developers of promising new medicines.