Liso-Cel Approved for R/R B-Cell Lymphoma by European Commission
The decision was based on findings from the phase 1 TRANSCEND NHL 001 clinical trial.
The European Commission has approved lisocabtagene maraleucel (liso-cel; Breyanzi; Bristol Myers Squibb) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) in patients who have received 2 or more lines of systemic treatment.
Data from the phase 1 TRANSCEND NHL 001 trial (NCT02631044) supported the approval. 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.
