Bristol Myers’ Breyanzi approved by FDA as new CAR T cell therapy in MCL

Bristol Myers Squibb announced yesterday that the U.S. FDA has granted approval for Breyanzi, a CD19-directed chimeric antigen receptor T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. “This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR T cell therapy available to treat the broadest array of B-cell malignancies,” the company stated. “With Breyanzi, we are delivering on the promise of cell therapy by offering a definitive treatment option for some of the most difficult-to-treat lymphomas,” said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb. Based on the U.S. Prescribing Information, in patients treated with Breyanzi and evaluated for efficacy, 85.3% responded to treatment, with 67.6% achieving a complete response, or CR, the company noted.