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June 27, 2022June 24, 2022 – The U.S. FDA has approved two new indications for Breyanzi® (lisocabtagene maraleucel), in the treatment of large B-cell lymphoma (LBCL).
- Breyanzi is now approved to treat LBCL in adults who:
- Have disease refractory to first-line chemoimmunotherapy or that has relapsed within 12 months of first-line chemoimmunotherapy; or
- Are not eligible for hematopoietic stem cell transplant due to comorbidities or age and have disease refractory to first-line chemoimmunotherapy or that has relapsed after first- line chemoimmunotherapy.
- First FDA approved in 2021, Breyanzi is also indicated to treat relapsed or refractory LBCL in adults who have received two or more lines of systemic therapy.
- Recommended dosing is individualized, as Breyanzi is a CAR-T therapy made using the patient’s own immune cells.