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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). KTE-X19 is a chimeric antigen receptor (CAR) T-cell therapy that targets the CD19 antigen on the surface of lymphoma cells. The Biologics License Application for KTE-X19 was previously accepted by the FDA in December 2019 for R/R MCL, supported with data from the ZUMA-2 clinical trial. The FDA target action date is August 10, 2020.
ZUMA-2
Results from the phase II ZUMA-2 study in patients with R/R MCL were presented at the 61st American Society for Hematology (ASH) meeting in Orlando, US, available here. The full results from this study were recently been published in The New England Journal of Medicine.
In 60 efficacy evaluable patients in the primary analysis, the overall response rate was 93%, with a complete response rate of 67%. Safety results showed 15% of patients experienced Grade 3 or higher cytokine release syndrome, and 31% experienced neurotoxicity of any grade. Two Grade 5 events occurred. At a median follow-up of 12.3 months, 57% of patients were in remission. The 12-month estimated progression-free survival and overall survival were 61% and 83%, respectively.2
The European Medicines Agency (EMA) has also fully validated the marketing authorization application.
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