Chronic lymphocytic leukemia European approval with BTK inhibitor venetoclax combination and hematology regulatory milestone
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AstraZeneca Receives European Commission Approval for Calquence Plus Venetoclax in CLL

AstraZeneca announces European Commission approval of Calquence (acalabrutinib) plus venetoclax for previously untreated chronic lymphocytic leukemia in the EU.

AstraZeneca today announced that the European Commission has approved Calquence (acalabrutinib) in combination with venetoclax for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL) in the European Union. The approval was based on results from the Phase 3 AMPLIFY trial, which demonstrated a statistically significant improvement in progression-free survival compared to chemoimmunotherapy. This approval makes Calquence plus venetoclax available as a fixed-duration chemotherapy-free treatment option for CLL patients across all EU member states.

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