Another FDA approval for BMS’ Breyanzi

The US Food and Drug Administration yesterday approved Bristol Myers Squibb’s (NYSE: BMY) Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi).

The US pharma major said 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. In relapsed or refractory MCL, is delivered as a one-time infusion with a single dose containing 90 to 110 x 10 CAR-positive viable T cells.

In March, Breyanzi became the first CAR-T approved for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and earlier this month, the FDA granted the cell therapy accelerated approval in relapsed or refractory follicular lymphoma. The one-time treatment was first authorized in the USA in 2021 for third-line large B-cell lymphoma.