BMS’ Breyanzi (lisocabtagene maraleucel) Receives EC’s Approval for Relapsed or Refractory Large B-cell Lymphoma
Shots:
- The EC has approved Breyanzi, a CD19-directed CAR T cell therapy for DLBCL, HGBCL, PMBCL & FL3B who relapsed within 12mos. from completion of or are refractory to 1L chemoimmunotherapy
- The approval was based on the P-III trial (TRANSFORM) evaluating Breyanzi vs SoC in 184 patients which showed improved EFS with a manageable and well-established safety profile, m-EFS (10.1 vs 2.3mos.) at the time of prespecified interim analysis with a median follow-up of 6.2mos.
- The primary analysis results were consistent with the interim analysis with a median follow-up of 17.5mos. & showed m-EFS (not reached vs 2.4mos.), CR (73.9% vs 43.5%) & m-PFS (not reached vs 6.2mos.). Breyanzi was approved in Japan for 2L treatment of r/r LBCL & in Japan, EU, Switzerland & Canada for r/r LBCL
Ref: BMS | Image: BMS
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