The FDA has approved Genentech’s Venclexta® (venetoclax) in combination with acalabrutinib for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL). The approval is based on results from the Phase III AMPLIFY study, which demonstrated that the combination regimen was superior to chemoimmunotherapy.
According to Genentech, the all-oral, fixed-duration regimen is the first of its kind designed to give patients the potential for time off treatment. Results from the AMPLIFY study showed the combination reduced the risk of disease progression or death by 35% compared with chemoimmunotherapy (hazard ratio 0.65; 95% CI: 0.49–0.87; p=0.0038). After a median follow-up of 42.6 months, median progression-free survival was not reached with the combination (95% CI: 51.1 months, not reached) versus 47.6 months for chemoimmunotherapy.
The safety profile of Venclexta plus acalabrutinib was consistent with the known profiles of each therapy. Common adverse reactions (≥20%) included neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19. Serious adverse reactions (≥2%) included COVID-19, second primary malignancies, and neutropenia.
Genentech stated that the approval expands its fixed-duration treatment portfolio, providing another first-line option in addition to Venclexta plus Gazyva®. CLL, one of the most common adult leukemias, often requires long-term management. Clinicians cited the new regimen as a significant addition to available fixed-duration approaches, offering patients a defined treatment timeline and the potential for durable responses.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!