AstraZeneca’s CALQUENCE plus Venetoclax Approved in the US as First All-Oral Fixed-Duration Regimen for First-Line CLL
Saturday, February 21, 2026
AstraZeneca has received approval from the U.S. Food and Drug Administration for CALQUENCE (acalabrutinib) in combination with venetoclax as a first-line treatment for adults with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adults with CLL or SLL. Known risks associated with the medicine include serious infections, bleeding events, low blood cell counts, second primary cancers, heart rhythm disorders and liver toxicity. Regular monitoring is recommended during treatment.
CLL is the most common type of leukaemia in adults. The disease is characterised by the build-up of abnormal lymphocytes in the blood, bone marrow and lymph nodes, which can lead to infection, anaemia and bleeding. Although some patients may not show symptoms at diagnosis, others may experience fatigue, weight loss, fever, night sweats and swollen lymph nodes.
The combination is the first all-oral, fixed-duration regimen approved in the United States for this setting.
The decision is based on results from the Phase III AMPLIFY trial, which evaluated the combination against standard chemoimmunotherapy.
Results showed that 77% of patients treated with CALQUENCE plus venetoclax remained progression-free at three years, compared with 67% of those receiving standard chemotherapy regimens. Median progression-free survival was not reached in the combination group, while it was 47.6 months in the chemoimmunotherapy group. The regimen reduced the risk of disease progression or death by 35% compared with standard treatment.
The safety profile of CALQUENCE in combination with venetoclax was consistent with previous data, and no new safety concerns were identified. The most commonly reported side effects included headache, diarrhoea, musculoskeletal pain, COVID-19 infection, fatigue, bruising, rash and nausea.
Serious adverse reactions occurred in a quarter of patients receiving the combination. Fatal events were reported in a small proportion of cases.
Source: businesswire.com
