FDA announces: The world's 4th CAR-T cell therapy has been approved for market, treatment of recurring or refractic large B-cell lymphoma, more safe!

On February 5, 2021, the U.S. Food and Drug Administration (FDA) announced approval for the development of Breyanzi (lisocabtagene maraleucel, liso-cel) by Juno Therapeutics, a subsidiary of BMS. Used to treat adult patients with recurring or incurable large B-cell lymphoma (R/R LBCL), including diffuse large B-cell lymphoma (DLBCL), who did not respond to at least 2 other systemic treatments or relapsed after treatment.
diffuse large B-cell lymphoma (DLBCL) is one of the most common and rapidly developing invasive diseases and is the most common form of non-Hodgkin's lymphoma, accounting for about two-thirds.
73% of patients did not respond or relapse during second-line treatment or later.
for patients who relapse or do not respond to initial therapy, routine treatments that provide a continuous response are limited, with a medium life expectancy of approximately six months.
who struggle with relapsed or incurable large B-cell lymphoma face daunting challenges, both physically and emotionally.
Breyanzi is the FDA-approved 3rd type of AUTOCAR-T cell therapy target CD19 and the 4th CAR-T cell therapy approved by the FDA.
, in addition to Breyanzi, the other three include Novart's Kymriah and Gilead's Yescarta and Tecartus.
, Breyanzi is CD19, as are the three CAR-T models previously listed, and there is no difference in adaptiveness.
In terms of safety and effectiveness, Breyanzi is unique in that it has good safety data compared to the other three CAR-T cell therapies, and because the ratio of CD8-positive to CD4-positive T-cells is controlled (1:1), Breyanzi is able to better control the toxic side effects of cell therapy.
's approval was based on a TRANSCEND NHL 001 clinical trial that evaluated more than 250 patients with recurring or recurring large B-cell lymphoma and found that a single dose of Breyanzi was used The post-total mitigation rate (ORR) was 73%, the full mitigation rate (CR) was 54%, the medium progression-free lifetime (PFS) was 6.8 months, and the medium total lifetime (OS) was 21.1 months.
patients who had received complete remission, the mesopfS and OS had not yet been reached, and at 12 months, 65.1 per cent had no progression and 85.5 per cent had survived.
results summary doi:10.1016/s0140-6736 (20) 31366-0 The safety data are significantly better than other CAR-T therapies and have a lower probability of inducing cytokine storms.
results showed that 46% of patients developed any level of cytokine release syndrome (CRS) and 2% of cytokine release syndrome of level 3 or higher.
the medium duration of CRS is 5 days (range: 1-30 days) and the medium onset time is 5 days (range: 1-15 days).
most common manifestations of CRS include fever (93%), low blood pressure (49%), tperforming heart rate (39%), chills (28%) and hypoxia (21%).
patients treated with Breyanzi, 35 percent had neurotoxic events of any grade (NT) and 12 percent had NT level 3 or higher.
in all patients, including those with persistent neurological events at the time of death or at the end of the data cutoff, the neurological toxicity was medium for 15 days.
the FDA may blacken the treatment due to severe or even fatal cytokine storms and neurotoxicity.
fda has developed a risk assessment and mitigation strategy that requires that medical institutions and doctors who use the therapy be specially certified.
, when using the therapy, doctors should be informed of cytokine release syndrome, neurological toxicity, and other adverse reactions that occur after treatment with Breyanzi.
to further evaluate long-term safety, the FDA also requires manufacturers to conduct post-market observational studies.
the FDA awarded Breyanzi Orphan Medicine, Advanced Therapy for Regenerative Medicine (RMAT) and Breakthrough Therapy.
RMAT was introduced in December 2016 as part of the U.S. 21st Century Cure Act to help accelerate the rapid development of regenerative medicine therapies for serious diseases, and the RMAT title accelerates the launch of innovative drugs for biotech companies.
Breyanzi was the first RMAT-certified regenerative medicine treatment to receive FDA approval.
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