Genentech's Venclexta and Acalabrutinib Combo Approved by FDA for Untreated CLL
- FDA approved Venclexta plus acalabrutinib for untreated CLL based on Phase III AMPLIFY study results.
- The combination reduced disease progression or death risk by 35% compared to chemoimmunotherapy.
- Median progression-free survival was not reached for the combination versus 47.6 months for chemoimmunotherapy.
- Common adverse reactions include neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19.
FDA Approval
The FDA has approved the combination of Venclexta (venetoclax) and acalabrutinib for the treatment of previously untreated chronic lymphocytic leukemia (CLL) in adults. This decision is based on the results from the Phase III AMPLIFY study.
AMPLIFY Study Results
The AMPLIFY study demonstrated that the Venclexta and acalabrutinib combination was superior to chemoimmunotherapy, reducing the risk of disease progression or death by 35%. At a median follow-up of 42.6 months, the median progression-free survival was not reached for the combination regimen, compared to 47.6 months for chemoimmunotherapy.
Safety Profile
The safety profile of the Venclexta and acalabrutinib combination is consistent with the known profiles of each therapy alone. Common adverse reactions include neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19. Serious adverse reactions include COVID-19 pneumonia, second primary malignancies, and neutropenia.
Significance for CLL Treatment
CLL is a common form of leukemia in adults, and while outcomes have improved, patients often face long treatment durations. The approval of this all-oral, fixed-duration regimen offers a new option for first-line treatment, providing patients with a clear and predictable treatment timeline.
Source: Genentech