AstraZeneca Receives FDA Approval for Calquence Plus Venetoclax in Frontline CLL

AstraZeneca today announced that the FDA has approved Calquence (acalabrutinib) in combination with venetoclax for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL). In the Phase 3 AMPLIFY trial, the combination demonstrated a statistically significant improvement in progression-free survival compared to chemoimmunotherapy. The 3-year PFS rate was 76.5% for Calquence plus venetoclax versus 66.5% for chemoimmunotherapy. This fixed-duration combination regimen offers patients a chemotherapy-free treatment option for frontline CLL. The approval expands the treatment options available for patients with newly diagnosed CLL.