WILMINGTON, Del. — The U.S. Food and Drug Administration has approved AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax as the first all-oral, fixed-duration treatment regimen for adults with chronic lymphocytic leukemia and small lymphocytic lymphoma in the first-line setting.
The approval is based on results from the Phase III AMPLIFY trial, which showed the combination delivered a statistically significant and clinically meaningful improvement in progression-free survival compared with standard chemoimmunotherapy. At three years, 77 percent of patients treated with Calquence plus venetoclax remained progression free, compared with 67 percent of those receiving chemotherapy.
Chronic lymphocytic leukemia is the most common form of leukemia in adults, with an estimated 18,500 patients treated in the first-line setting in the United States in 2024.
“The continuous regimens frequently used to treat chronic lymphocytic leukemia often come with side effects that may become burdensome to patients over time,” said Jennifer Brown, M.D., Ph.D., director of the CLL Center in the Division of Hematologic Malignancies at Dana-Farber Cancer Institute and principal investigator of the AMPLIFY trial. “The U.S. 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.”
In the AMPLIFY study, median progression-free survival was not reached for patients treated with the Calquence–venetoclax combination, compared with 47.6 months for those receiving chemoimmunotherapy. The combination reduced the risk of disease progression or death by 35 percent versus chemotherapy.
Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology Business Unit, said the decision represents a significant shift in frontline care. “Today’s approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the U.S. for the treatment of chronic lymphocytic leukemia,” he said. “This Calquence combination has the potential to meaningfully change first-line treatment decisions and underscores our commitment to improving the standard of care for people living with blood cancers.”
Patient advocacy groups also welcomed the approval, highlighting the benefits of a time-limited therapy. “Managing an incurable blood cancer that progresses slowly can often feel indefinite and overwhelming,” said Gwen Nichols, M.D., chief medical officer of Blood Cancer United. “We welcome new treatment options that may ease the burden, restore a sense of control and offer renewed hope for those navigating life with chronic lymphocytic leukemia.”
AstraZeneca said the safety and tolerability profile of Calquence in combination with venetoclax was consistent with the drug’s known safety profile, with no new safety signals identified in the trial.
The Calquence–venetoclax regimen is already approved in the European Union, Canada, the United Kingdom, and several other countries, with additional regulatory reviews ongoing worldwide.
