EC Grants Approval to Lisocabtagene Maraleucel

The European Commission (EC) has granted approval to lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma (LBCL) after one prior therapy.

The EC approval covers the treatment of adult patients with diffuse LBCL, high-grade BCL, primary mediastinal LBCL, and follicular lymphoma grade 3B who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

The approval is based on results from the pivotal phase III TRANSFORM trial in which the drug demonstrated statistically significant and clinically meaningful improvements in the study’s primary endpoint of event-free survival (EFS) and key secondary endpoints of complete responses (CR) and progression-free survival (PFS) compared with standard therapy, according to the manufacturer of the drug.

In the TRANSFORM study, lisocabtagene maraleucel increased median EFS more than four times compared with standard therapy (10.1 months vs 2.3 months) at the time of the prespecified interim analysis, with a median follow-up of 6.2 months. The primary analysis results were consistent with the interim analysis, with lisocabtagene maraleucel not reaching median EFS. Standard therapy had a median EFS of 2.4 months (median follow-up, 17.5 months). Lisocabtagene maraleucel resulted in a higher CR rate (73.9%) than standard therapy (43.5%). Median PFS was not reached with lisocabtagene maraleucel, and it was 6.2 months with standard therapy.

Source: Bristol Myers Squibb, May 2023