Friday, AbbVie Inc. (ABBV) announced that the European Commission has authorized an expanded label for VENCLYXTO to include use in combination with acalabrutinib and use in combination with ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia.
The expanded label comes after the Commission includes these combinations in the acalabrutinib and ibrutinib labels.
Notably, VENCLYXTO in combination with acalabrutinib, with or without obinutuzumab, was supported by data from the Phase 3 AMPLIFY trial, which showed that the combination regimen reduced the risk of disease progression or death by 35% versus chemoimmunotherapy.
Meanwhile, VENCLYXTO in combination with ibrutinib was supported by data from the Phase 3 GLOW and Phase 2 CAPTIVATE trials, which found that the fixed-duration combination regimen demonstrated a clinically meaningful improvement in PFS and overall survival compared to chlorambucil plus obinutuzumab at 64-month follow-up.
The authorization extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.
In the pre-market hours, ABBV is trading at $218.73, up 0.06 percent on the New York Stock Exchange.
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