By VETTAPHARMA reporter: AstraZeneca PLC (LSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved Calquence® (acalabrutinib) in combination with venetoclax as the first all-oral, fixed-duration treatment regimen for adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the first-line setting. The decision follows positive results from the global 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.
In the AMPLIFY study, the fixed-duration Calquence plus venetoclax combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with standard chemoimmunotherapy. At three years, 77% of patients treated with the Calquence regimen were progression free, compared with 67% of those receiving standard therapies. Median PFS was not reached in the Calquence arm versus 47.6 months with chemoimmunotherapy, and the risk of disease progression or death was reduced by 35% (hazard ratio 0.65; 95% CI: 0.49–0.87; p=0.0038).
The FDA’s approval marks a first-in-class, all-oral, fixed-duration option for adults with CLL and SLL. This 14-month regimen may offer greater convenience and a defined treatment course compared with continuous therapies currently used in first-line settings — a meaningful consideration for both patients and clinicians managing a typically indolent disease.
CLL is the most common form of leukemia in adults, with an estimated 18,500 first-line patients treated in the U.S. in 2024. The new approval builds on Calquence’s established hematology portfolio and may influence treatment patterns by providing an alternative to prolonged continuous BTK inhibitor therapy.
Principal investigators and hematology experts have highlighted that the fixed-duration regimen’s combination of efficacy, tolerability, and a defined treatment timeline could support more personalized care strategies for patients and help manage long-term treatment burden.
Source credit:
AstraZeneca PLC. (2026, February). Calquence plus venetoclax approved in the U.S. as first all-oral, fixed-duration combination for CLL and SLL. Click here
