The approval was granted by the US Food and Drug Administration (FDA) and follows positive AMPLIFY Phase III trial results.
This trial enrolled patients from 2019 to 2021.
The data from the global, randomised, multi-centre, open-label AMPLIFY study demonstrated that 77% of patients who received Calquence plus venetoclax remained progression free at three years, compared to 67% for those on standard chemotherapy.
Median progression-free survival was not achieved with the new regimen versus 47.6 months for chemoimmunotherapy. The combination reduced the risk of progression or death by 35%.
The tolerability and safety of Calquence were observed to be consistent with its known safety profile. No new safety signals were reported.
The combination holds approvals in Canada, the European Union, the UK and other countries, with further applications under review worldwide.
AstraZeneca oncology haematology business unit executive vice-president Dave Fredrickson said: “Today’s approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukaemia.
“This Calquence combination has the potential to meaningfully change first-line chronic lymphocytic leukaemia treatment decisions and underscores our commitment to improving on the current standard of care for people living with blood cancers.”
Last month, AstraZeneca outlaid up to $18.5bn in a licensing deal with China-based CSPC Pharmaceuticals to develop longer-lasting weight-loss drugs, becoming the latest drugmaker to pursue entry into the obesity market.