Weekly Digest - 25-31 Mar 2023

Weekly Digest - 25-31 Mar 2023

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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