NORTH CHICAGO - AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
The approval is supported by data from the Phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies and updated data from the Phase 1b M14-358 and the Phase 1/2 M14-387 studies. The FDA previously granted accelerated approval to VENCLEXTA for this indication in 2018.5
'AML is a complex and challenging disease with generally low survival rates. This approval is significant because data from our VIALE-A trial has shown that newly-diagnosed patients, who cannot undergo intensive chemotherapy, lived longer when treated with VENCLEXTA plus azacitidine than those treated with azacitidine alone,' said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology development, AbbVie. 'This trial also provides physicians more information for managing patients - from treatment initiation, to assessing response and management post disease remission.'
Positive overall survival (OS) data seen at an interim analysis of the VIALE-A trial led to an early submission supporting the FDA approval of VENCLEXTA in AML. The trial showed patients on the active regimen of VENCLEXTA plus azacitidine achieved a 34% reduction in the risk of death compared to azacitidine in combination with placebo (Hazard Ratio [HR]=0.66 [95% CI: 0.52-0.85], p
(C) 2020 Electronic News Publishing, source ENP Newswire