Europe backs AstraZeneca’s fixed-duration Calquence combo for CLL

AstraZeneca (LSE: AZN) has received European approval for a fixed-duration regimen of Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, for adults newly diagnosed with chronic lymphocytic leukemia (CLL).

The green light follows a positive opinion from the European Medicines Agency's (EMA) scientific panel and is based on findings from the Phase III AMPLIFY trial. That study showed that patients on the Calquence combinations were more likely to remain progression-free at three years compared to those on standard chemoimmunotherapy. The treatment arms also demonstrated a significant reduction in the risk of disease progression or death.