On February 5, 2021, the U.S. FDA granted approval of Breyanzi (lisocabtagene maraleucel) to Juno Therapeutics, a Bristol-Myers Squibb Company. Breyanzi is a chimeric antigen receptor (CAR) T cell therapy approved for the treatment of adults with relapsed or refractory large-B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. The earliest CAR-T approvals, Kymriah and Yescarta, have been commercially available since 2017 and 2018, respectively. They’ve been infused into nearly a half million patients worldwide. In July 2020, the U.S. FDA approved a third CAR-T cell therapy, Kite Pharma’s brexucabtagene autoleucel (sold as Tecartus). Breyanzi now joins the list to become the fourth CAR-T approval within the U.S. Breyanzi is also the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of non-Hodgkin lymphoma in adults.
For further information, see BioInformant ( FDA Approves Fourth CAR-T Cell Therapy (Breyanzi) to Juno Therapeutics (bioinformant.com) )