SPRING SILVER, Md., February 5, 2021 / PRNewswire / – Today, the United States 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 who do not did not respond or who relapsed afterwards, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.
“Today’s approval represents another milestone in the rapidly evolving field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow and lymph nodes lymphatics, “said Pierre Marc, MD, Ph.D., Director of the Center for Biologics Evaluation and Research, FDA. “GEnoid and cell therapy have moved from promising concepts to practical regimens for cancer treatment. ”
DLBCL is the most common type of non-Hodgkin lymphoma in adults. Non-Hodgkin lymphomas are cancers that start in certain cells of the immune system and can be fast growing (aggressive) or slow growing. About 77,000 new cases of non-Hodgkin lymphoma are diagnosed in the United States each year, and LDGCB accounts for about one in three newly diagnosed cases.
Each dose of Breyanzi is a personalized treatment created using the patient’s own T cells, a type of white blood cell, to help fight lymphoma. The patient’s T cells are collected and genetically engineered to include a new gene that makes it easier to target and kill lymphoma cells. Once the cells have been modified, they are reinjected into the patient.
The safety and efficacy of Breyanzi have been established in a multi-center clinical trial involving more than 250 adults with refractory or relapsed large B-cell lymphoma. The rate of complete remission after treatment with Breyanzi was 54%.
Treatment with Breyanzi can cause serious side effects. Labeling includes a boxed warning for cytokine release syndrome (CRS), which is a systemic response to activation and proliferation of CAR T cells, causing high fever, flu-like symptoms and neurological toxicities . CRS and neurological events can be life threatening. Other side effects include hypersensitivity reactions, serious infections, low blood cell count, and a weakened immune system. Side effects usually appear within one to two weeks of treatment, but some side effects may occur later.
Due to the risk of CRS and neurological toxicities, Breyanzi is in the process of being approved with a Risk Assessment and Mitigation Strategy (REMS) which includes elements to ensure safe use (ETASU). The FDA requires, among other things, that healthcare facilities that dispense Breyanzi be specially certified. As part of this certification, personnel involved in prescribing, dispensing or administering Breyanzi must be trained to recognize and manage the risks of CRS and neurological toxicities. The REMS program specifies that patients should be informed of the signs and symptoms of CRS and neurological toxicities after the infusion – and the importance of returning to the treatment site promptly if they develop fever or other side effects afterwards. have received treatment with Breyanzi.
To further assess long-term safety, the FDA is also asking the manufacturer to conduct a post-market observational study involving patients treated with Breyanzi.
The FDA has granted Breyanzi Orphan drug, Advanced therapy in regenerative medicine (RMAT) and Revolutionary therapy designations. The RMAT designation program was established under the 21st Century Cures Act to help facilitate the rapid development of regenerative medicine therapies for serious illnesses. Breyanzi is the first regenerative medicine therapy with the RMAT designation to be approved by the FDA. The orphan drug designation provides incentives to help and encourage drug development for rare diseases. Breyanzi’s application was reviewed using a coordinated, interagency approach, including both the Center for Biologics Assessment and Research and the FDA Center of Excellence in Oncology.
The FDA granted Breyanzi approval to Juno Therapeutics Inc., a Bristol-Myers Squibb company.
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SOURCE US Food and Drug Administration