EMA Tecartus (Brexucabtagene Autoleucel) Approved for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) on December 17, 2020

EMA Tecartus (Brexucabtagene Autoleucel) Approved for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) on December 17, 2020

On December 17, 2020, Gilead’s subsidiary Kite’s CD19 CAR-T cell therapy Tecartus (KTE-X19) received conditional marketing authorization in the European Union for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL).

This CAR-T therapy was previously granted accelerated approval by the U.S. FDA on July 24, 2020, becoming the first and only approved CAR-T cell therapy for the treatment of MCL globally. In October 2020, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, recommending conditional approval of Gilead/Kite’s CAR-T product Tecartus.

The conditional approval of Tecartus was based on the pivotal multinational, single-arm, open-label ZUMA-2 trial, which enrolled 74 adults with relapsed/refractory MCL. Among the 68 treated patients, they had previously received anthracycline or bendamustine-containing chemotherapy, anti-CD20 antibody, and BTK inhibitor (ibrutinib or acalabrutinib) therapies.

Mantle cell lymphoma (MCL) is a rare subtype of non-Hodgkin’s lymphoma (NHL), caused by the malignant transformation of cells in the mantle zone of lymph nodes. It is more common in males over 60 years of age. MCL is highly aggressive upon relapse. In China, MCL accounts for approximately 3.5% of new NHL cases, with about 3,100 new patients annually.

Tecartus (KTE-X19) is Kite’s CD19 autologous CAR-T therapy developed using its XLP manufacturing process, which includes T-cell selection and lymphocyte enrichment. For certain B-cell malignancies with circulating lymphoblasts, lymphocyte enrichment is a necessary step. Tecartus has been granted PRIME (PRIority MEdicines) designation by the EMA for relapsed or refractory MCL.

According to the independent radiological review committee’s assessment of the ZUMA-2 trial after a single infusion of Tecartus, the overall response rate (ORR) was 93%, with 67% of patients achieving a complete response (CR). In the safety analysis, 15% and 33% of patients experienced Grade 3 or higher cytokine release syndrome (CRS) and neurological toxicity events, respectively.

Professor John G. Gribben, a medical oncologist from London, stated: “For mantle cell lymphoma patients whose disease progresses after initial treatment, there remains a significant unmet need. This is the first cell therapy approved for relapsed or refractory MCL in patients who have received at least two prior systemic therapies, including a BTK inhibitor, providing an important new option for European patients.”

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