KTE-X19 receives CHMP positive opinion for the treatment of patients with R/R MCL

On October 16, 2020, KTE-X19 received positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

The autologous anti-CD19 CAR T-cell product, KTE-X19, is now recommended in Europe for the treatment of adults with R/R MCL who have received ≥ 2 lines of prior therapy including a Bruton’s tyrosine kinase inhibitor. It was in January 2020 that the Marketing Authorization Application for KTE-X19 was fully validated by the European Commission prior to evaluation by the EMA.

Promising results from the ongoing phase II ZUMA-2 trial (NCT02601313), evaluating the efficacy and safety of KTE-X19 in patients with R/R MCL, provided the foundations for these decisions. For the full study design and results presented at the 61st American Society of Hematology (ASH) meeting in Orlando, US, click here. The final efficacy and safety data were recently published in The New England Journal of Medicine, and are summarized by the Lymphoma Hub here.

KTE-X19 was also granted accelerated approval by the U.S. Food and Drug Administration (FDA) in July 2020, making it the first CAR T-cell therapy approved for the treatment of MCL.

This CHMP recommendation is currently under review by the European Commission and a decision regarding the marketing authorization of KTE-X19 is expected in the coming months.