SILVERLENTE, Md., 5 February 2021 / PRNewswire / – Today, the US Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma that have not responded, or that have relapsed to, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T-cell therapy, is the third FDA-approved gene therapy for certain types of non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi has not been identified for the treatment of patients with primary central nervous system lymphoma.
“Today’s approval represents another milestone in the rapidly advancing field of gene therapy by providing an additional treatment option for adults with certain cancers affecting the blood, bone marrow and lymph nodes,” he said. Peter Marks, MD, Ph.D., director of the FDA’s Center for Biological Evaluation and Research. “Gones and cell therapies have evolved from promising concepts to practical governments for cancer treatment. ‘
DLBCL is the most common type of non-Hodgkin’s lymphoma in adults. Non-Hodgkin’s lymphomas are cancers that start in certain cells of the immune system and can grow rapidly (aggressively) or slowly. About 77,000 new cases of non-Hodgkin’s lymphoma are diagnosed annually in the U.S. and DLBCL represents about one in three newly diagnosed cases.
Each dose of Breyanzi is a custom treatment made using the patient’s own T cells, a type of white blood cell, to fight the lymphoma. The patient’s T cells are collected and genetically modified to include a new gene that allows the focus and killing of the lymphoma cells. Once the cells have been altered, they are re-administered into the patient.
The safety and efficacy of Breyanzi were established in a multicenter clinical trial involving more than 250 adults with refractory or relapsed large B-cell lymphoma. The overall remission rate after treatment with Breyanzi was 54%.
Treatment with Breyanzi can cause serious side effects. The label contains a warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T cells, causing high fever and flu-like symptoms and neurological toxicities. Both CRS and neurological events can be life-threatening. Other side effects include hypersensitivity reactions, serious infections, low blood cell counts and a weakened immune system. Side effects usually occur within the first one to two weeks after treatment, but some side effects may occur later.
Because of the risk of CRS and neurological toxicity, Breyanzi is approved with a risk assessment and mitigation strategy (REMS) that includes elements to ensure safe use (ETASU). Among other things, the FDA demands that health care facilities that Breyanzi distributes must be specially certified. As part of the certification, personnel involved in prescribing, dispensing, or administering Breyanzi must be trained to recognize and manage the risks of CRS and neurological toxicity. The REMS program states that patients should be informed about the signs and symptoms of CRS and neurological toxicities after infusion – and how important it is to return to the treatment site immediately if they develop a fever or other side effects after treatment with Breyanzi. is.
To further evaluate long-term safety, the FDA also requires the manufacturer to conduct an observational post-marketing study in which patients are treated with Breyanzi.
The FDA has approved Breyanzi Orphan Drugs, Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy appointments. The RMAT designation program was created among the 21st Century Cures Act to facilitate the rapid development of regenerative medicine therapies intended for serious conditions. Breyanzi is the first regenerative drug therapy with RMAT designation licensed by the FDA. The designation of orphan drugs provides incentives to help and encourage the development of drugs for rare diseases. The Breyanzi application was reviewed using a coordinated approach between agencies, which includes the Center for Biological Evaluation and Research and the Fc Oncology Center of Excellence.
The FDA has approved Breyanzi for Juno Therapeutics Inc., a Bristol-Myers Squibb company.
Media contact: Monique Richards, 240-402-3014
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SOURCE US Food and Drug Administration
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