European Commission Approves Liso-Cel for Select Relapsed/Refractory Large B-Cell Lymphoma

The European Commission approved lisocabtagene maraleucel for the treatment of certain patients with relapsed/refractory large B-cell lymphoma.

Lisocabtagene maraleucel (liso-cel; Breyanzi) had been approved by the European Commission for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) following 2 of more lines of systemic treatment, according to a press release from Bristol Myers Squibb.

The decision was based on findings from the phase 1 TRANSCEND NHL 001 trial (NCT02631044), which assessed liso-cel in patients with relapsed/refractory DLBCL, PMBCL, and FL3B. In a population of 216 patients with a range of histologies and high-risk disease, investigators reported that 73% (95% CI, 67%-78.5%) of patient responded. Of these patients, 53% (95% CI, 47%-60%) had minimal or no detectable disease following infusion. Among responders, the median duration of response was 20.2 months.

“Advancing cell therapies is a significant part of our commitment to deliver innovative and potentially curative treatments in order to transform the lives of people living with cancer,” Samit Hirawat, MD, chief medical officer at Bristol Myers Squibb, said in a press release. “[Liso-cel] addresses an ongoing unmet need for patients in Europe battling relapsed or refractory large B-cell lymphoma who have few treatment options that provide long-term remission. The EC approval of Breyanzi is a significant step towards bringing the novel and personalized science of CAR T-cell therapies to more patients around the world.”

Liso-cel was previously approved by the FDA in February 2021 in the same population of patients with certain types of large B-cell lymphoma based on the TRANSCEND NHL 001 trial.


Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for certain forms of relapsed or refractory large B-cell lymphoma. News release. Bristol Myers Squibb. April 5, 2022. Accessed April 8, 2022.

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