ET 10:06

AbbVie (ABBV) Secures EU Approval for Expanded VENCLYXTO Label in CLL Treatment

IMP5.5
SNT+0.6
CONF95%
Regulatory

AbbVie Inc. (ABBV) said on May 29, 2026, that the European Commission approved an expanded label for VENCLYXTO, authorizing the venetoclax tablet for a broader population of adults with chronic lymphocytic leukemia (CLL). The approval allows VENCLYXTO’s use in combination with a CD20 monoclonal antibody for previously untreated CLL patients, according to the company. The decision marks the first regulatory nod in Europe for this first-line combination regimen. The label expansion builds on VENCLYXTO’s existing EU indications for relapsed or refractory CLL. AbbVie did not immediately disclose the financial impact of the approval. VENCLYXTO is jointly commercialized with Roche, and the drug generated $2.3 billion in global sales in 2025.

EditorLim