Weekly Digest - 29 Apr-05 May 2023

Weekly Digest - 29 Apr-05 May 2023

May 03, 2023: Breyanzi (IV) / R/R Large B-cell Lymphoma / BMS: Received EU approval

  • EU approval of Breyanzi was based on the positive data from the pivotal Phase 3 TRANSFORM study evaluating Breyanzi in comparison to SOC

  • It demonstrated statistically significant and clinically meaningful improvements in the study’s primary endpoint of event-free survival (EFS)

    • 10.1 months vs. 2.3 months
  • It has a manageable and well-established safety profile

    • Any-grade CRS: 48.9%
    • Grade 3 CRS: 1%
  • This marks the approval of our third indication in Europe for our CAR T cell therapy portfolio, underscoring our continued drive to deliver the promise of cell therapy with curative potential for more patients.” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb

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