31 Mar 2023: Breyanzi (Lisocabtagene Maraleucel) / 2L NHL / BMS: Granted Positive CHMP opinion in EU
BMS announced positive CHMP opinion for Breyanzi to treat 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 or are refractory to, first-line chemoimmunotherapy
European Commission decision is expected within 2 months, which generally follows the CHMP’s advice
Recommendation for approval is based on the Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier lines of therapy in this patient population
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