AbbVie Inc. (NYSE: ABBV) received European Commission authorization to expand the label for its cancer drug VENCLYXTO to include additional combination treatments for previously untreated chronic lymphocytic leukemia patients.

The authorization allows VENCLYXTO (venetoclax) to be used in combination with acalabrutinib, with or without obinutuzumab, and in combination with ibrutinib for treating adult patients with previously untreated CLL. The approval extends to all European Union member states, as well as Iceland, Norway and Liechtenstein.

The expanded label was supported by data from three clinical trials: the Phase 3 AMPLIFY trial for the acalabrutinib combination, the Phase 3 GLOW trial for the ibrutinib combination, and the Phase 2 CAPTIVATE trial for the ibrutinib combination.

In the AMPLIFY study, the VENCLYXTO and acalabrutinib combination reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy. The GLOW study showed the VENCLYXTO and ibrutinib combination reduced the risk of disease progression or death by 73% compared to chlorambucil plus obinutuzumab at 64 months follow-up.

VENCLYXTO is a BCL-2 protein inhibitor developed jointly by AbbVie and Roche. The drug is approved in more than 80 countries for various blood cancer treatments. These new combinations offer fixed-duration, oral treatment options that may provide patients with treatment-free intervals.

CLL is one of the most common forms of leukemia in adults, developing from cells in bone marrow that mature into certain white blood cells called lymphocytes.