Global biopharma leader Bristol Myers Squibb has scored another major regulatory win, announcing FDA approval of Breyanzi (lisocabtagene maraleucel; liso-cel) for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic treatments. 

 

The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population—an expansion that further cements the drug’s reach across B-cell cancers.

 

“The FDA approval of Breyanzi for relapsed or refractory marginal zone lymphoma further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients," said Lynelle B Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. 

 

“Breyanzi is the first and only CAR T cell therapy approved for this patient population, demonstrating Bristol Myers Squibb’s deep commitment to expanding access and reaching as many patients as possible with this innovative, practice-changing treatment.”

 

The decision hinges on strong Phase 2 data from the TRANSCEND FL study. Among 66 evaluable patients, Breyanzi delivered a striking overall response rate of 95.5%, including a 62.1% complete response rate. Most responders—90%—were still in response at 24 months, and median duration of response has not yet been reached.

 

For clinicians, the clearance marks a pivotal moment for a disease where treatments often stop working over time. 

 

“Patients living with marginal zone lymphoma, a subtype of indolent non-Hodgkin lymphoma, generally see success with initial therapy, but a subset of patients ultimately experience multiple relapses over the course of many years, creating a pressing need for new treatment options with durable outcomes,” said M. Lia Palomba, TRANSCEND FL study investigator and lymphoma and cell therapy specialist at Memorial Sloan Kettering Cancer Center. 

 

“The FDA approval of liso-cel in relapsed or refractory marginal zone lymphoma is a significant advancement in redefining the treatment landscape and providing patients with an option that has demonstrated high rates of responses with an established safety profile.”