Drug Approval | August 06, 2025
AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients
The submission is supported by positive results from the Phase 3 AMPLIFY trial
The submission is supported by positive results from the Phase 3 AMPLIFY trial
AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
First and only BTK inhibitor to demonstrate favourable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting
First BTK inhibitor to show favourable trend in overall survival vs. standard-of-care chemoimmunotherapy in this setting
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