Dr. Hill on the Approval of Brexucabtagene Autoleucel in MCL

Brian T. Hill, MD, PhD, director of the Lymphoid Malignancies Program and staff physician at Taussig Cancer Institute, as well as an assistant professor of hematology and oncology at the Cleveland Clinic, discusses the approval of brexucabtagene autoleucel (Tecartus) in mantle cell lymphoma (MCL).

​In July 2020, the FDA approved brexucabtagene autoleucel to treat patients with relapsed/refractory MCL based on findings from the phase 2 ZUMA-2 trial. The CD19-directed CAR T-cell therapy ​elicited an 87% objective response rate with a 62% complete response rate among this patient population.

With the regulatory decision, brexucabtagene autoleucel can now be used outside of a clinical trial, says Hill.

​ Although the ZUMA-2 trial evaluated patients who received prior BTK inhibitors, such as ibrutinib (Imbruvica) and acalabrutinib (Calquence), the indication states that the therapy can be used to treat all adult patients with relapsed/refractory MCL, Hill concludes.