FDA Approves Calquence Plus Venetoclax as First All-Oral Fixed-Duration CLL Treatment
FDA approves AstraZeneca's Calquence plus venetoclax as first all-oral, 14-month fixed-duration regimen for first-line chronic lymphocytic leukemia, with 77% of patients progression-free at three years in Phase III trial.
AstraZeneca has secured U.S. FDA approval for Calquence (acalabrutinib) in combination with venetoclax as the first all-oral, fixed-duration regimen for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. The 14-month combination is intended to offer an effective, time-limited alternative to continuous treatment, giving physicians more flexibility to align therapy with patient needs.
The approval by the US Food and Drug Administration 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. 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.
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).
The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified.
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. The expanded label in the U.S., alongside ongoing global regulatory reviews, underscores the company's strategy to build a leading haematology franchise and may increase uptake of its BTK inhibitor-based regimens in a large and growing CLL population.
AstraZeneca is also developing Calquence further as a single agent and in combinations across multiple B‑cell malignancies, including mantle cell lymphoma and diffuse large B‑cell lymphoma.