Tecartus Approved for the Treatment of Patients with Relapsed or Refractory Mantle-Cell Lymphoma

On July 24, 2020, the FDA approved brexucabtagene autoleucel (Tecartus; Kite Pharma), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients diagnosed with mantle-cell lymphoma (MCL) who have not responded to, or who have relapsed following, other kinds of treatment. Tecartus is an autologous CAR T-cell therapy that targets the CD19 protein on the surface of cancer cells. The FDA granted Tecartus a priority review and an orphan drug designation.

“Tremendous progress has been made in the discovery of new therapies for debilitating diseases that are difficult to treat. This approval is yet another example of customized treatments that use a patient’s own immune system to help fight cancer, while using a scientific advance in this promising new area of medicine. We’re seeing continued advances in the field of gene therapy and remain committed to supporting innovation in this promising new area of medicine,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.

The FDA approval of brexucabtagene autoleucel was based on results of the ongoing, pivotal, single-arm ZUMA-2 clinical trial that enrolled 74 patients with relapsed or refractory MCL. In the study, 87% of patients responded to a single dose of the Tecartus, including 62% of patients who achieved a complete response.

The most common (≥10%) grade 3 or higher adverse events with Tecartus were anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy, leukopenia, hypoxia, pyrexia, hyponatremia, hypertension, infection-pathogen unspecified, pneumonia, hypocalcemia, and lymphopenia.

Brexucabtagene autoleucel will include a boxed warning that outlines risks for cytokine release syndrome and neurotoxicity associated with CAR T-cell therapy.

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