Bristol Myers Squibb gets positive EMA Committee opinion for Breyanzi for Relapsed or Refractory Large B-cell Lymphoma after one prior therapy
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells.;

Princeton: Bristol Myers Squibb has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
“This positive CHMP opinion is an important milestone towards introducing a potential new standard of care for people in the European Union living with relapsed or refractory large B-cell lymphoma after first-line treatment, an area of critical unmet need where few patients are able to undergo or derive long-term clinical benefit from stem cell transplant,” said Anne Kerber, senior vice president, Cell Therapy Development, Bristol Myers Squibb. “We look forward to continuing to work with the European Medicines Agency with the goal of bringing our cell therapy, Breyanzi, and the potential for cure to more people.”
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