AbbVie’s $2.5B Drug Venetoclax Fails to Improve Survival in Phase 3 Trial

On June 17, 2025, AbbVie announced that its blockbuster cancer drug venetoclax failed to meet the primary endpoint of overall survival (OS) in patients with higher-risk myelodysplastic syndrome (HR-MDS) during the VERONA Phase 3 trial. The hazard ratio (HR) was reported at 0.908, indicating no significant benefit.

The global trial compared venetoclax combined with azacitidine to azacitidine plus placebo. Despite the disappointing results, the company confirmed the outcome will not affect the drug's existing approvals. Venetoclax, co-developed with Roche, is currently used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML).

In 2024, venetoclax generated $2.5 billion in global sales. AbbVie stated that further data from the trial will be presented at an upcoming medical congress. The drug, marketed as Venclexta in the US, is known for targeting the BCL-2 protein, which prevents cancer cell death, helping restore apoptosis.