AstraZeneca (NASDAQ:AZN) announced on Friday that the U.S. Food and Drug Administration (FDA) has approved its BTK inhibitor, Calquence (acalabrutinib), in combination with venetoclax as the first all-oral, fixed-duration treatment for adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The landmark approval allows patients to complete their treatment course in just 14 months, providing a finite alternative to the continuous "treat-to-progression" regimens that have long been the standard of care.
By offering a time-limited option, the therapy aims to reduce the long-term side-effect burden and financial strain on the roughly 18,500 Americans who start first-line CLL treatment annually.
The FDA’s decision was underpinned by data from the Phase III AMPLIFY trial, which demonstrated that 77% of patients treated with the Calquence-venetoclax combo remained progression-free at three years, compared to 67% of those on standard chemoimmunotherapy.
The trial showed a 35% reduction in the risk of disease progression or death, with a safety profile consistent with the individual medications.