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Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy

Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier lines of therapy in this patient population ... | March 31, 2023
United Kingdom Bristol Myers Squibb Anne Kerber European Medicines Agency Bristol Myers Squibb Company Cell Therapy Development

Liso-cel Receives European Approval Recommendation for Relapsed/Refractory LBCL

The European Medicines Agencyโ€™s Committee for Medicinal Products for Human Use has recommended the approval of lisocabtagene maraleucel for the treatment of select patients with large B-cell lymphoma who relapsed within 12 months from completion of or developed refractory disease to frontline chemoimmunotherapy.
Bristol Myers Squibb Anne Kerber European Union European Commission European Medicines Agency Cell Therapy Development

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European Medicines Agency Validates Bristol Myers Squibb's Application for CAR T Cell Therapy Breyanzi in Relapsed or Refractory Large B-cell Lymphoma After First-Line Therapy

Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its type II variation application for extension of the indication for Breyanzi (lisocabtagene maraleucel) to treat adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL) ...
Anne Kerber Bristol Myers Squibb Drug Administration Bristol Myers Squibb Company Exchange Commission Japan Ministry Of Health

Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) Significantly Improves Outcomes, Showing Superiority Over 20-Year Standard of Care in Second-Line Relapsed or Refractory Large B-cell Lymphoma Based on TRANSFORM Study Results

Phase 3 TRANSFORM study shows Breyanzi significantly improved event-free survival (EFS) vs. chemotherapy plus autologous stem cell transplant, with a 65% reduction in risk of EFS events in first disclosure of results presented at ASH 2021Breyanzi showed a manageable safety profile and no new safety signals observed,...
United States Manali Kamdar Anne Kerber Bristol Myers Squibb Meeting Press Program University Of Colorado Cancer Center

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