20 February 2026 -- AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Key Efficacy Highlight of the Combination Regimen
Calquence plus venetoclax demonstrated statistically significant and clinically meaningful improvement in progression-free survival vs. chemoimmunotherapy, with 77% of patients progression free at three years in AMPLIFY Phase III trial.
Basis for FDA Approval
The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine.
Overview of Chronic Lymphocytic Leukemia (CLL)
CLL is the most common type of leukemia in adults. An estimated 18,500 people were treated for CLL in the 1st-line setting in the US in 2024.
Expert Commentary (AMPLIFY Trial Principal Investigator)
Jennifer Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and the Worthington and Margaret Collette Professor of Medicine at Harvard Medical School, and principal investigator of the AMPLIFY trial, said: “The continuous regimens frequently used to treat chronic lymphocytic leukemia often come with side effects that may become burdensome to patients over time. 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.”
AstraZeneca Official Commentary
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Today’s approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukemia. This Calquence combination has the potential to meaningfully change 1st-line chronic lymphocytic leukemia treatment decisions and underscores our commitment to improving on the current standard of care for people living with blood cancers.”
Commentary from Blood Cancer United
Gwen Nichols, MD, Chief Medical Officer of Blood Cancer United, formerly The Leukemia & Lymphoma Society, said: “Managing an incurable blood cancer that progresses slowly can often feel indefinite and overwhelming. 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.”
Detailed AMPLIFY Phase III Trial Results
Results from the AMPLIFY Phase III trial showed 77% of patients treated with Calquence plus venetoclax were progression free at three years, versus 67% of patients treated with standard-of-care chemotherapy (investigator’s choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab). Median progression-free survival (PFS) was not reached versus 47.6 months for chemoimmunotherapy. Further, Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy (based on hazard ratio 0.65; 95% confidence interval 0.49-0.87; p=0.0038).
Global Approval Status of the Regimen
Calquence plus venetoclax is approved in the European Union, Canada, UK and several other countries, and regulatory applications for the regimen based on the AMPLIFY results are currently under review in additional countries.
