The European Commission (EC) has granted approval to Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

“This approval for Breyanzi in relapsed or refractory mantle cell lymphoma marks another important step as we continue to deliver on the promise of cell therapy for more eligible patients across Europe – the fourth approval for Breyanzi in Europe,” said Emma Charles, senior vice president, Europe Region, Bristol Myers Squibb. “While frontline therapies have advanced over the years for this rare but aggressive form of non-Hodgkin lymphoma, the vast majority of patients relapse or become resistant and face reduced survival outlook, leaving a critical need for new treatment options. Breyanzi has the opportunity to address a treatment gap for this patient population based on its demonstrated clinical benefit.”

The decision was based on data from the MCL cohort of the TRANSCEND NHL 001 trial, which showed an overall response rate of 82.7% and a complete response rate of 71.6% in heavily pretreated patients. Responses were rapid, with a median time to first response of 0.95 months, and durable, with more than half of patients maintaining response at 24 months.

Safety findings were consistent with Breyanzi’s established profile. Cytokine release syndrome occurred in 61% of patients, with severe cases in 1%, and neurologic events in 31%, including 9% grade three or four.

The approval applies across the EU and EEA and marks Breyanzi’s fourth indication in Europe, adding to existing approvals for several aggressive B-cell lymphomas.