WILMINGTON, DE — AstraZeneca said the U.S. Food and Drug Administration has approved CALQUENCE (acalabrutinib) in combination with venetoclax as a fixed-duration, all-oral treatment for adults with chronic lymphocytic leukemia and small lymphocytic lymphoma.
The approval is based on results from the Phase III AMPLIFY trial, which were presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine, the company said.
Chronic lymphocytic leukemia, or CLL, is the most common type of leukemia in adults. About 18,500 people were treated for CLL in the first-line setting in the United States in 2024, according to the company.
In the AMPLIFY trial, 77% of patients treated with CALQUENCE plus venetoclax were progression-free at three years, compared with 67% of patients who received standard chemotherapy regimens. Median progression-free survival was not reached in the combination arm, compared with 47.6 months for chemoimmunotherapy.
The combination reduced the risk of disease progression or death by 35% compared with chemotherapy, based on a hazard ratio of 0.65 with a 95% confidence interval of 0.49 to 0.87 and a p-value of 0.0038.
“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,” said Jennifer Brown, principal investigator of the AMPLIFY trial and director of the CLL Center at Dana-Farber Cancer Institute.
Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology Business Unit, said the approval marks the first fixed-duration regimen in the United States based on a BTK inhibitor for first-line CLL treatment.
CALQUENCE plus venetoclax has also been approved in the European Union, Canada and the United Kingdom, and applications are under review in additional countries, AstraZeneca said.
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