AstraZeneca has secured approval in the US for Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration regimen to treat adults with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the first-line setting.
The approval was granted by the US Food and Drug Administration (FDA) and follows positive AMPLIFY Phase III trial results.
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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.
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By GlobalDataThe 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.
