US-based major AbbVie Inc., (NYSE: ABBV) has revealed disappointing data for its Venclexta (venetoclax) in combination with azacitidine in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). The first-in-class BCL-2 inhibitor failed to meet the primary endpoint of overall survival (OS) in the global Phase III VERONA study, although no new safety signals were observed.
Study Details
The VERONA study compared the efficacy and safety of the venetoclax/azacitidine combination against azacitidine plus placebo. Despite the setback, AbbVie and Roche, who co-developed Venclexta/Venclyxto, remain committed to advancing BCL-2 research. The therapy is jointly commercialized in the US by AbbVie and Genentech (a Roche Group company), with AbbVie leading ex-US commercialization.
Global Authorization and Ongoing Research
Venetoclax is currently approved in over 80 countries, including the US, and holds marketing authorization under dual brand names in different regions. The partners continue ongoing clinical investigations of venetoclax across multiple hematologic malignancies and solid tumors.-Fineline Info & Tech
