Breyanzi, the CAR-T cell therapy of Shishi Shiguibo, has been approved by the FDA

, the U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb's CD19 CAR-T cell therapy, Breyanzi (lisocabtagene maraleucel, liso-cel) for the treatment of adult patients with recurring or incurable large B-cell lymphoma treated in two or more systemic treatments.This Breyanzi therapy can be approved, relying primarily on efficacy and safety data from transCEND NHL 001 clinical trials. The results showed that in more than 250 patients with assessable efficacy, the total remission rate (ORR) of Breyanzi therapy reached 73%, and 54% of patients treated with Breyanzi achieved complete remission (CR). At 6 months of medium follow-up, 60.4% of patients still had a therapeutic response, while 54.7% of patients at 12 months continued to show an efficacy response.In addition, the drug's experimental results were better than those of the approved ZUMA-1 trial of the same CAR-T therapy Yescarta and the JULIET trial of Kymriah, with CR rates of 51% and 32%, respectively. In terms of safety, only 6 (2%) patients treated with Breyanzi developed 3/4 cytokine release syndrome (CRS), while yescarta and Kymriah had rates of 13% and 23%.Breyanzi is the fourth CAR-T cell therapy approved by the FDA. Breyanzi's approval provides patients with a new treatment option and a milestone in the field of cell immunotherapy. Previously, Breyanzi therapy was awarded the title of Advanced Therapy for Regenerative Medicine (RMAT), Orphan Medicine and Breakthrough Therapy by the FDA. Each dose of Breyanzi is a personalized treatment using the patient's in vitro T cells, first the patient's T cells are collected, then genetically modified, adding new genes that help target and kill lymphoma cells, and then the modified T cells are returned to the patient to achieve the effect of attacking tumor cells."CAR-T cell therapy Breyanzi will play an important role in the clinical practice of oncology, providing patients with recurring or resuscable large B-cell lymphoma with long-lasting remission and personalized treatment options," said Dr. Samit Hirawat, Chief Medical Officer, Breitger. Today's FDA approval reflects Therbo's strong commitment to advancing cell therapy research, developing innovative therapies, and providing ongoing support at every step of the patient's treatment process. "B-cell lymphoma is the most common type of non-Hodgkin's lymphoma in adults, accounting for about one-third of new cases of non-Hodgkin's lymphoma each year. Analysts estimate that sales of Breyanzi therapy are expected to exceed $100 million by 2021. The FDA noted that the treatment's approval was accompanied by a label warning of serious side effects that could result from treatment, such as CRS, a systemic response to CAR-T cell activation and proliferation that can lead to high fever, flu-like symptoms and neurotoxicity.The FDA also requires that the medical institutions that distribute the drug be specially certified. As part of the certification, staff involved in Breyanzi prescription, dosing or administration must undergo rigorous training to be able to identify and manage CRS and the risk of neurotoxicity. In addition, to further evaluate The long-term safety of Breyanzi, the FDA requires manufacturers to conduct post-market observational studies of patients who use Breyanzi.The drug was acquired when Pershing-Segba bought Celgene for $74 billion in 2019. Breyanzi was due to be approved on November 16, 2020, but the approval was delayed because of the new crown pneumonia pandemic. After the approval, The Times said in a statement that it plans to produce Brenyanzi for patients in need of treatment at its immunotherapy manufacturing facility in Bossel, Washington. (Sina Pharmaceutical News
)Reference: 1.New Hope for B-Cell Lymphoma Patients as FDA Approves BMS' CAR-T Therapy 2.FDA OK Bristol-Myers Squibb's Breyanzi To Treat Large-B-Cell Lymphoma 3.FDA Approves Breyanzi for Adults with Relapsed, Refractory Large B-cell Lymphoma