AstraZeneca's Calquence leukaemia treatment gets US FDA approval
By Josh White
Date: Friday 20 Feb 2026
(Sharecast News) - AstraZeneca said on Friday that the US Food and Drug Administration has approved its 'Calquence', or acalabrutinib, in combination with venetoclax as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma in the first-line setting.
The FTSE 100 drugmaker said the approval was based on results from the phase three 'AMPLIFY' trial, which were presented at the American Society of Hematology 2024 Annual Meeting and published in the New England Journal of Medicine.
In the study, 77% of patients treated with the Calquence plus venetoclax combination were progression free at three years, compared with 67% of those receiving investigator's choice of chemoimmunotherapy, either fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab.
Median progression-free survival was not reached in the combination arm versus 47.6 months for chemoimmunotherapy, and the regimen reduced the risk of disease progression or death by 35%, with a hazard ratio of 0.65.
"The continuous regimens frequently used to treat chronic lymphocytic leukaemia often come with side effects that may become burdensome to patients over time," said Jennifer Brown, principal investigator of the AMPLIFY trial and director of the CLL Center at Dana-Farber Cancer Institute.
"The US approval of the Calquence combination offers patients an all-oral, 14-month, fixed-duration treatment option that is highly effective and well-tolerated, and gives physicians greater flexibility to tailor treatment plans for individual patient needs and goals."
Dave Fredrickson, executive vice-president of AstraZeneca's oncology haematology business unit, added that the approval delivered 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," he said.
Chronic lymphocytic leukaemia is the most common type of leukaemia in adults, with an estimated 18,500 people treated in the first-line setting in the US in 2024.
The safety and tolerability profile of Calquence in combination with venetoclax was said to be consistent with the known safety profile of Calquence, and no new safety signals were identified.
Calquence plus venetoclax is also approved in the European Union, Canada and the UK, with regulatory applications under review in additional countries.
At 1022 GMT, shares in AstraZeneca were up 0.57% at 15,376.40p.
Reporting by Josh White for Sharecast.com.
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