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.
AMPLIFY Phase III Trial Data
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.
Efficacy Highlights: 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 currently under review worldwide.
Corporate Context
This regulatory milestone follows major strategic moves by the company. 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 highly competitive obesity market.
