Global biopharma giant Bristol Myers Squibb has scored a major European approval for its CAR-T cell therapy Breyanzi. This gives a new hope to adults with relapsed or refractory mantle cell lymphoma (MCL) who have exhausted standard treatments.

 

The European Commission’s green light marks Breyanzi’s fourth indication in Europe and extends access to patients across all EU and EEA countries. It does not apply to the UK.

 

“This approval marks another important step as we continue to deliver on the promise of cell therapy for more eligible patients across Europe,” said Emma Charles, senior vice president for the company’s Europe region. She noted that despite advances in frontline treatment, most MCL patients eventually relapse or become resistant, creating an urgent need for new options.

 

The decision leans on data from the MCL cohort of the TRANSCEND NHL 001 study. In patients who had tried at least two prior therapies — including a BTK inhibitor — Breyanzi achieved an 82.7% overall response rate, with 71.6% reaching complete response. Many patients responded quickly, within about one month, and more than half of responders remained in remission at two years.

 

Safety outcomes tracked with the therapy’s established profile. Cytokine release syndrome — a well-known CAR-T side effect — occurred in 61% of patients, though only 1% experienced severe cases. Neurologic events were reported in 31% of patients, with 9% severe. Most side effects emerged within the first two weeks, reinforcing recent shifts to shorter monitoring requirements.

 

Breyanzi is already authorized in the EU for multiple hard-to-treat lymphomas, including DLBCL, HGBCL, PMBCL, and FL3B, in both first-relapse and later-line settings. The new approval adds MCL — a rare, aggressive cancer that makes up about 3% of non-Hodgkin lymphoma cases and often returns despite treatment.

 

Made from a patient’s own reengineered T cells, Breyanzi is delivered as a one-time infusion after a multistep manufacturing process that includes cell collection, genetic modification, and lymphodepletion.

 

With the EC’s latest decision, Bristol Myers Squibb further cements its position as a key player in Europe’s fast-expanding CAR-T therapy landscape — and brings a powerful new option to patients running out of them.