BMS's Breyanzi is first CAR-T for marginal zone lymphoma

Bristol Myers Squibb has taken CAR-T therapy of blood cancers into new territory, after getting FDA approval for Breyanzi as a treatment for relapsed or refractory marginal zone lymphoma (MZL).

CD19-targeted therapy Breyanzi (lisocabtagene maraleucel) can now be used to treat adults with MZL – a rare and form of non-Hodgkin lymphoma (NHL) – who have previously received at least two lines of systemic therapy. MZL accounts for approximately 7% of all B-cell NHL cases in the US.

It is the seventh FDA approval across five blood cancer types for Breyanzi – coming after it was previously cleared for indications in chronic lymphocytic leukaemia (CLL), large B-cell lymphoma (LBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL) – and will add to the growth momentum for the CAR-T, which is poised to break the $1 billion sales threshold this year.

The approval is based on an MZL cohort in the TRANSCEND FL study, an open-label, single-arm trial. Among 66 patients who received a single infusion of BMS's CAR-T, 95.5% of patients experienced a response to treatment, and 62.1% of patients had a complete response without signs of MZL on imaging scans. According to the FDA, the responses were durable over a median follow-up of 21.6 months.

MZL is classed as an indolent (slow-growing) form of NHL, with most patients getting a favourable outcome from initial treatment, but it can develop into a more aggressive disease.

"Patients living with marginal zone 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 Lia Palomba, a TRANSCEND FL study investigator and lymphoma and cell therapy specialist at Memorial Sloan Kettering Cancer Center in the US.

She added that the new approval "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."

Sales of Breyanzi doubled in the first nine months of 2025 to reach $966 million, of which $709 million came from the US market.

With the ASH congress due to start at the weekend, an important trial readout for Breyanzi could be a head-to-head comparison of the CAR-T with Lyell Immunopharma's experimental CD19/CD20-directed bispecific CAR-T – rondecabtagene autoleucel (ronde-cel) – as second-line therapy for aggressive (LBCL).

The phase 1/2 study is also seeing how Lyell's therapy compares with Gilead's CD9-targeted CAR-T Yescarta (axicabtagene ciloleucel).