The European Commission (EC) has granted marketing authorisation for Gilead Sciences’ subsidiary Kite’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), to treat adults with relapsed or refractory follicular lymphoma (FL).
A CD19-directed genetically modified autologous T cell immunotherapy, Yescarta is indicated for FL patients who have received three or more previous lines of systemic therapy.
The treatment has maintained orphan medicinal product designation for this indication.
The latest approval is based on findings from the global, single-arm Phase II ZUMA-5 clinical trial in 122 relapsed or refractory FL patients.
These subjects received a minimum of two lines of systemic therapy previously, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent.
At the 24-month assessment, subjects who received three or more lines of previous therapy had an overall response rate (ORR) and complete response (CR) rate of 91% and 77%, respectively.
The median duration of response (DoR) was reported to be 38.6 months while the proportion of responders who were still in response at month 24 was 56%.
Safety observations were in line with Yescarta’s known safety profile.
In the trial, 6% of the subjects had Grade ≥3 cytokine release syndrome (CRS) while 16% of them had neurologic events.
Kite CEO Christi Shaw said: “Patients with advanced relapsed or refractory follicular lymphoma have a high need for new treatment options.
“This is the third approved indication for a Kite cell therapy in Europe, and we are pleased to enable more patients with different lymphomas greater access to this treatment innovation.”
FL is a kind of indolent non-Hodgkin lymphoma (iNHL).
In April this year, the US Food and Drug Administration (FDA) granted approval for Yescarta for adult patients with large B-cell lymphoma.
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