29 July 2025 - Application is supported by data from the Phase 3 AMPLIFY trial that showed statistically significant improvement in progression-free survival vs chemoimmunotherapy.
AbbVie announced the submission of a supplemental new drug application to the US FDA for the fixed-duration, all-oral combination regimen of Venclexta (venetoclax) and acalabrutinib in previously untreated patients with CLL, offering CLL patients another Venclexta combination regimen with the potential for time-limited treatment.
Read AbbVie press release