AbbVie, Roche's Venclexta nails confirmatory combo trial in AML after flopping earlier study
Venclexta received an accelerated FDA approval for AML on the condition of performing three confirmatory trials. (AbbVie)
Weeks after AbbVie and Roche's blood cancer med Venclexta flopped a confirmatory trial in acute myeloid leukemia (AML), the partners hoped for a win to keep their med's chances alive. Now, a Venclexta-chemo combo has hit its marks in a second trial, easing concerns the drug's label will take a major hit.
A combination of Venclexta and chemotherapy azacitidine beat out azacitidine alone at extending AML patients' lives and rates of remission, according to top-line results from the phase 3 Viale-A trial released Monday.
Data from the study will be reported early, per an independent data monitoring committee's recommendation, and submitted to the FDA and global health authorities, AbbVie said in a release. The companies will unveil the details at a future medical meeting or in a peer-reviewed journal.