FDA Approves First All-Oral Fixed-Duration Treatment for Chronic Lymphocytic Leukemia
The FDA approved AbbVie's combination of Venclexta and acalabrutinib as the first all-oral, fixed-duration treatment for previously untreated chronic lymphocytic leukemia patients, based on Phase 3 trial data showing 35% reduction in disease progression risk.
The U.S. Food and Drug Administration approved the combination of Venclexta (venetoclax) and Calquence (acalabrutinib) as the first all-oral, fixed-duration treatment for previously untreated patients with chronic lymphocytic leukemia (CLL), a slow-growing blood cancer where the bone marrow produces too many dysfunctional B-lymphocyte white blood cells.
AbbVie and Roche Holdings AG are jointly developing Venclexta, while AstraZeneca manufactures Calquence. This milestone provides patients with a new, targeted option that may allow for time off treatment, enhancing the standard of care. CLL is one of the most common forms of leukemia in adults.
The FDA approval was based on positive results from the AMPLIFY Phase 3 trial that 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. Median progression-free survival was not reached versus 47.6 months for chemoimmunotherapy.
The combination reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy. The new regimen is expected to improve patient outcomes by offering an all-oral, time-limited treatment option that addresses patient needs for rapid and flexible treatment solutions.
The safety profile of the Venclexta and acalabrutinib combination is consistent with each drug used alone, with common adverse reactions including neutropenia, headache, and diarrhea, ensuring patient safety and tolerability during treatment.