AstraZeneca Announces US FDA Approval of Fixed-Duration Calquence and Venetoclax Combination for First-Line CLL and SLL Treatment

AstraZeneca Announces US FDA Approval of Fixed-Duration Calquence and Venetoclax Combination for First-Line CLL and SLL Treatment

AstraZeneca’s Calquence (acalabrutinib) in combination with venetoclax has been approved by the U.S. Food and Drug Administration as the first all-oral, fixed-duration regimen for adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), based on positive results from the Phase III AMPLIFY trial showing significant improvements in progression-free survival compared with standard chemoimmunotherapy. The 14-month treatment option offers a time-limited alternative to continuous therapies and has the potential to change first-line treatment decisions for people living with these blood cancers.

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