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On January 19, 2021, the National Institute for Health and Care Excellence (NICE) for England issued guidance stating that KTE-X19 could be considered under a managed access agreement, via the Cancer Drugs Fund, for the treatment of adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), who have previously received treatment with a Bruton’s tyrosine kinase inhibitor.1
KTE-X19, an autologous, anti-CD19-transduced CD3+, chimeric antigen receptor-T cell therapy, has previously been granted approval by the U.S. Food and Drug Administration (FDA) and a conditional approval by the European Medicines Agency (EMA) for the treatment of R/R MCL.
The NICE recommendation was based on results of the ongoing phase II ZUMA-2 study (NCT02601313), in a modified intent-to-treat group (n = 68). Results showed a promising overall response rate and an extension to life for patients that achieved a complete response to KTE-X19. However, at the latest data cut-off (December 2020), the median follow-up time was short, and the survival data were immature. Therefore, the NICE committee have asked for further data to be collected on progression-free survival and overall survival. A 3-year follow up is needed to provide reliable evidence of a cure.2
Currently, the National Health Service (NHS) has ten providers around the country that will be able to offer KTE-X19 as a treatment option for R/R MCL.1
KTE-X19 granted priority review by US FDA for R/R mantle cell lymphoma
The United States Food & Drug Administration (FDA) has granted priority review to KTE-X19 for the treatment of patients with relapsed/refectory (R/R) mantle cell lymphoma (MCL).
Brexucabtagene autoleucel receives FDA approval for the treatment of relapsed/refractory mantle cell lymphoma
On July 24, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (formerly KTE-X19),...
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