AbbVie submits for US FDA approval of combination treatment of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukaemia

AbbVie

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

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier , Registration