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What is Lisocabtagene maraleucel and explain in detail?
Lisocabtagene maraleucel, sold under the brand name Breyanzi, is a cell-based gene therapy used to treat large B-cell lymphoma.Side effects include hypersensitivity reactions, serious infections, low blood cell counts, and a weakened immune system. The most common side effects include decreases in neutrophils (a type of white blood cell that fights infections), in red blood cells or in blood platelets (components that help the blood to clot), as well as cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure) and tiredness.Lisocabtagene maraleucel, a chimeric antigen receptor (CAR) T cell (CAR-T) therapy, is the third gene therapy approved by the U.S. Food and Drug Administration (FDA) for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Lisocabtagene maraleucel was approved for medical use in the United States in February 2021.

Medical uses
Lisocabtagene maraleucel is indicated for the treatment of adults with relapsed or refractory large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B).Lisocabtagene maraleucel is indicated for the treatment of adults with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within twelve months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age.Lisocabtagene maraleucel is not indicated for the treatment of people with primary central nervous system lymphoma.

Adverse effects
The labeling carries a boxed 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 neurologic toxicities.

History
Lisocabtagene maraleucels safety and efficacy were established in a multicenter clinical trial of more than 250 adults with refractory or relapsed large B-cell lymphoma. The complete remission rate after treatment was 54%.The U.S. Food and Drug Administration (FDA) granted lisocabtagene maraleucel priority review, orphan drug, regenerative medicine advanced therapy (RMAT), and breakthrough therapy designations. Lisocabtagene maraleucel is the first regenerative medicine therapy with RMAT designation to be licensed by the FDA. The FDA granted approval of Breyanzi to Juno Therapeutics Inc., a Bristol-Myers Squibb Company.Efficacy was evaluated in TRANSFORM (NCT03575351), a randomized, open-label, multicenter trial in adults with primary refractory LBCL or relapse within twelve months of achieving complete response (CR) to first-line therapy. Participants had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous HSCT