The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s lisocabtagene maraleucel (Breyanzi) as a chimeric antigen receptor (CAR) T-cell therapy for adults with relapsed or refractory mantle cell lymphoma (MCL).
In the MCL cohort of the TRANSCEND NHL 001 trial, liso cel achieved an overall response rate of 85.3% following a one-time infusion. The therapy also demonstrated a consistent safety profile across clinical trials, reinforcing its potential as a manageable and effective option for eligible patients, according to the company’s press release.
This expanded approval brings personalized cellular therapy to a broader range of patients with B-cell malignancies, according to the company.
