NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended approval for Bristol Myers Squibb's autologous CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) as a third- or later-line treatment for adults with relapsed or refractory follicular lymphoma.
The committee based its decision on results from the Phase II TRANSCEND FL study, which enrolled patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. In the trial, follicular lymphoma patients who received Breyanzi in the third- or later-line setting had an overall response rate of 97 percent and a complete response rate of 94 percent. Patients also had durable responses to Breyanzi, with 76 percent still responding at 18 months.
The CHMP recommendation will now be reviewed by the European Commission, which is expected to decide whether to grant marketing authorization within two months of receiving the committee's opinion.
The US Food and Drug Administration approved Breyanzi in this same setting in May 2024. In Europe, Breyanzi is already approved for relapsed or refractory diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and third-line grade 3B follicular lymphoma.
Two other CAR T-cell therapies are already approved for later-line treatment of relapsed or refractory follicular lymphoma in Europe, including Gilead's Yescarta (axicabtagene ciloleucel) as a fourth-line treatment and Novartis' Kymriah (tisagenlecleucel) in the third-line setting.