Shots:

• The EMA’s CHMP has recommended the approval of Breyanzi for adult patients with DLBCL, HGBCL, PMBCL & FL3B who relapsed within 12mos. from completion of, or are refractory to 1L chemoimmunotherapy
• The opinion was based on the P-III study (TRANSFORM) evaluating Breyanzi vs SoC consisting of salvage CT, followed by high-dose CT + HSCT in 184 patients. The EC’s final decision is expected within ~2mos. following receipt of the CHMP opinion
• The EC’s decision will be valid to all EU member states, Iceland, Norway, and Liechtenstein. Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain & was approved in Japan for 2L treatment of r/r LBCL & in Japan, EU, Switzerland & Canada for r/r LBCL
   

  Ref: bristol myers squibb | Image: bristol myers squibb