AstraZeneca secures US approval for oral Calquence plus venetoclax with 35% risk reduction
AstraZeneca secured FDA approval for its all-oral, fixed-duration Calquence plus venetoclax regimen in first-line CLL/SLL. AMPLIFY Phase III data showed 77% of patients progression-free at three years versus 67% on chemoimmunotherapy, median PFS not reached versus 47.6 months and a 35% reduction in progression or death risk.
1. US FDA Approval for Calquence plus Venetoclax
On 23 February 2026, FDA granted approval for AstraZeneca’s all-oral, fixed-duration combination of Calquence (acalabrutinib) plus venetoclax in first-line chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). This marks the first oral BTK inhibitor-based fixed-duration regimen authorised in the US for these indications.
2. AMPLIFY Phase III Efficacy Results
The global AMPLIFY Phase III study enrolled patients from 2019 to 2021, demonstrating that 77% of participants receiving the combination remained progression-free at three years versus 67% on chemoimmunotherapy. Median progression-free survival was not reached with the new regimen compared to 47.6 months for standard treatment, representing a 35% lower risk of progression or death.
3. Safety and Tolerability
The safety profile of the Calquence plus venetoclax regimen aligned with known tolerability data for both agents, with no new adverse event signals reported. Common side effects were consistent with prior trials and manageable under established dose modification guidelines.
4. Global Approvals and Strategic Outlook
The combination already holds marketing authorisations in Canada, the EU, the UK and other regions, with additional applications under regulatory review worldwide. Last month, AstraZeneca also committed up to $18.5 billion in a licensing agreement to develop longer-acting weight-loss therapies, underscoring its expansion into adjacent therapeutic markets.