FDA Grants Priority Review for Relapsed/Refractory MCL Treatment
While KTE-X19 is not yet approved in any country, its Marketing Authorization Application has been validated in the European Union, and its target action date in the United States is August 10, 2020.
The FDA has accepted the Biologics License Application (BLA), and granted priority review for KTE-X19, an investigational chimeric antigen receptor T cell therapy for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). The review was granted to Kite, a Gilead Company.1
MCL is a rare form of non-Hodgkin lymphoma that arises from cells originating in the mantle zone of the lymph node. It typically affects men over age 60 years.1 The condition has a poor prognosis even with intensive therapy: The median overall survival is between 6 and 7 years, which is significantly shorter than indolent subtypes of non-Hodgkin’s lymphoma.2
KTE-X19 uses the XLP manufacturing process, including T-cell selection and lymphocute enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature.1
Supporting the BLA, the single-arm, open-label ZUMA-2 trial included 74 enrolled/leukapheresed adult patients ages 18 years or older, whose disease is refractory to or has relapsed following up to 5 prior lines of therapy. The objectives were to evaluate the efficacy and safety after a single infusion of KTE-X19.1
While the study is ongoing, initial reports have been encouraging. Early results showed that 93% of patients responded to a single infusion of the treatment, including 67% of patients who achieved a complete response. In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15% and 31% of patients, respectively. No Grade 5 CRS or neurologic events were observed.1
While KTE-X19 is not yet approved in any country, its Marketing Authorization Application has been validated in the European Union, and its target action date in the United States is August 10, 2020.1
- U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma [news release]. Gilead Sciences website; February 10, 2020. http://investors.gilead.com/news-releases/news-release-details/us-fda-grants-priority-review-kites-kte-x19-biologics-license. Accessed February 11, 2020.
- Mantle cell lymphoma. Cancer Therapy Advisor website; https://www.cancertherapyadvisor.com/home/decision-support-in-medicine/hematology/mantle-cell-lymphoma/. Accessed February 11, 2020.