BRIEF—FDA nod for BMS' CAR-T cell therapy Breyanzi in two indications

25 June 2022

The US Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, from Bristol Myers Squibb, for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:

Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age.

With these two new indications, Breyanzi now has the broadest patient eligibility of any CAR T cell therapy in relapsed or refractory LBCL, according to BMS.

Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.