AstraZeneca has received approval from the US Food and Drug Administration (FDA) for the combination of Calquence (acalabrutinib) with venetoclax as the first all-oral, fixed-duration regimen for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).[1][2] The approval is based on the results of the phase three AMPLIFY trial, which showed a statistically significant improvement in progression-free survival in patients treated with the combination versus standard chemoimmunotherapy.[1][2] After three years, 77% of patients on the combination were progression-free, compared to 67% in the chemoimmunotherapy group.[1] Median progression-free progression was not reached in the combination arm, while it was 47.6 months in the chemoimmunotherapy arm.[1] The combination reduced the risk of disease progression or death by 35% (hazard ratio 0.65; 95% confidence interval 0.49–0.87; p=0.0038).[1][4] Treatment with Calquence plus venetoclax lasted a fixed 14 cycles of 28 days, with no new safety issues.[1][2] The AMPLIFY study was conducted from 2019 to 2021 in 27 countries.[1] The combination is already approved in the European Union, Canada, the United Kingdom and other countries.[1][2]