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The Food and Drug Administration on Friday approved Breyanzi, a cell-based gene therapy, for the treatment of adults with certain types of large B-cell lymphoma.
The Food and Drug Administration (FDA) approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy, to treat adults with certain types of large B-cell lymphoma who have either relapsed following, or not responded to, two previous lines of systemic treatment.
“Today's approval represents another milestone in the rapidly progressing 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,” said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, in an agency-issued press release. “Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens.”
Breyanzi, according to the agency, becomes the third gene therapy approved to treat certain types of non-Hodgkin lymphoma.
The decision was based on safety and efficacy data from a multicenter clinical trial. Among more than 250 adults with relapsed/refractory large B-cell lymphoma, treatment with Breyanzi induced a complete remission rate of 54%.
The FDA noted the approval comes with a boxed warning for cytokine release syndrome (CRS), which can cause high fever and flu-like symptoms as well as brain toxicities and may lead to death. Some of the other side effects the agency noted were associated with treatment included, but were not limited to, serious infections, low blood cell counts and a weakened immune system.
Because of these side effect concerns, patients are only able to receive this treatment at health care facilities specially certified to administer Breyanzi.