AbbVie (ABBV) submitted a supplemental New Drug Application, or sNDA, to the FDA for the fixed-duration, all-oral combination regimen of venclexta – venetoclax – and acalabrutinib in previously untreated patients with Chronic Lymphocytic Leukemia, or CLL. The submission is based on the positive results from the Phase 3 AMPLIFY trial. The combination regimen of venclexta and acalabrutinib improved progression-free survival compared to standard chemoimmunotherapy in previously untreated patients with CLL.
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