NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended Bristol Myers Squibb's autologous CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma patients who've received one prior therapy.
The CHMP recommendation is based on results from the Phase III TRANSFORM clinical trial, in which BMS pitted Breyanzi against a standard-of-care regimen involving salvage chemotherapy and high-dose chemo plus a stem cell transplant. In the randomized trial, patients treated with Breyanzi lived longer without their cancers progressing than did patients treated with the control regimen.
Last June, the US Food and Drug Administration approved Breyanzi for this second-line lymphoma indication, and BMS submitted an application to European regulators around that same time.
Meanwhile, Breyanzi's main competitor, Gilead Sciences' autologous CD19-directed CAR T-cell therapy Yescarta (axicabtagene ciloleucel) netted second-line LBCL approval in Europe last October.
Following the CHMP opinion, the European Commission will decide whether to approve Breyanzi for this indication within roughly two months. The approval would make Breyanzi available on the commercial market to patients with LBCL — including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B — across all EU member states as well as Iceland, Norway, and Liechtenstein.