The U.S. Food and Drug Administration has approved a new all-oral treatment combination of acalabrutinib (Calquence) and venetoclax (Venclexta) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This is the first fixed-duration treatment in the U.S. that combines a BTK inhibitor with venetoclax, meaning patients can complete therapy in a set period rather than staying on continuous treatment.
The approval is based on results from the Phase 3 AMPLIFY trial, which compared the two-drug combination with standard chemoimmunotherapy. After about 41 months of follow-up, 76.5% of patients receiving acalabrutinib plus venetoclax were free from disease progression at three years, compared with 66.5% in the standard treatment group. Overall survival at three years was also higher with the combination, at 94.1% versus 85.9%. The full treatment course lasts 14 months.
No new safety concerns were found. The most common serious side effects included neutropenia (32.3%), infections (12.4%), high blood pressure (2.7%), and heart-related events (1.7%). Experts say this approval provides an effective, time-limited option that may reduce long-term side effects and give doctors more flexibility in tailoring treatment plans to individual patients.