CHMP Recommends Approval of Fixed-Duration Calquence-Based Regimens for Untreated Chronic Lymphocytic Leukaemia in the EU
Tuesday, April 29, 2025
AstraZeneca’s Calquence (acalabrutinib), in combination with venetoclax, with or without obinutuzumab, has been recommended for approval in the European Union for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued the positive opinion based on data from the AMPLIFY Phase III trial. These results were shared at the American Society of Haematology 2024 Annual Meeting and published in The New England Journal of Medicine.
Findings from the study showed that the fixed-duration regimen of Calquence and venetoclax reduced the risk of disease progression or death by 35% compared to standard chemoimmunotherapy. When combined with obinutuzumab, the reduction in risk increased to 58%.
At the three-year mark, 77% of patients receiving Calquence and venetoclax, and 83% of those on the triple combination with obinutuzumab, remained progression-free. In contrast, 67% of patients receiving standard treatment achieved the same outcome. The median progression-free survival was not reached in either of the experimental arms, while it was 47.6 months in the chemoimmunotherapy group.
Chronic lymphocytic leukaemia is the most common form of leukaemia in adults, with around 27,000 new cases expected in the UK, France, Germany, Spain, and Italy in 2024.
The safety profile of Calquence in the trial was consistent with previous findings, and no new safety concerns were identified.
Regulatory reviews for these fixed-duration regimens are ongoing in several countries, supported by the AMPLIFY study results.
Source: astrazeneca.com
