The European Commission has approved the use of acalabrutinib in combination with venetoclax, with or without obinutuzumab, for the frontline treatment of CLL. The decision is based on the results of the Phase 3 AMPLIFY trial, which demonstrated that using the all-oral, fixed-duration regimen or the regimen with IV obinutuzumab significantly improved progression-free survival compared to standard chemoimmunotherapy.
The approval provides the option of a time-limited, all-oral chemotherapy-free treatment for chronic lymphocytic leukemia patients, aligning with the growing preference for targeted oral therapies that allow for treatment cessation after a defined period.
The USA used to be the leader in new drug approvals, but this is the second all-oral therapy (the first was ibrutinib and venetoclax or I+V) to be approved in Europe but not in the USA, at least not yet. Unlike I+V, which will likely never be approved by the FDA, it’s anticipated that the acalabrutinib-based combination therapies will be approved in the USA soon.
You can read the official AstraZeneca Press Release (June 6, 2025) here: EU Approval of Calquence (acalabrutinib) combinations in CLL.
