All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.

The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your Lymphoma Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.
2020-04-16T13:26:12.000Z

KTE-X19 granted priority review by US FDA for R/R mantle cell lymphoma

Apr 16, 2020
Share:

Bookmark this article

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.

  1. HemOnc Today. Kite’s CAR-T for mantle cell lymphoma receives priority review. https://www.healio.com/hematology-oncology/practice-management/news/print/cell-therapy-next/%7B2f17dda5-4fc5-4088-97fb-78ccee039a3e%7D/kites-car-t-for-mantle-cell-lymphoma-receives-priority-review. Published Apr 2020. Accessed Apr 15, 2020.
  2. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma.N Engl J Med. 2020;382:1331-1342. DOI: 1056/NEJMoa1914347

Understanding your specialty helps us to deliver the most relevant and engaging content.

Please spare a moment to share yours.

Please select or type your specialty

  Thank you

Newsletter

Subscribe to get the best content related to lymphoma & CLL delivered to your inbox