AstraZeneca PLC (AZN) on Friday said the US Food and Drug Administration (FDA) has approved its Calquence in combination with venetoclax for the treatment of adults with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said, "Today's approval delivers the first all-oral, fixed-duration BTK inhibitor-based regimen in the US for the treatment of chronic lymphocytic leukaemia."
The approval was based on results from the Phase III AMPLIFY trial, which showed 77% of patients treated with Calquence- venetoclax combo were progression free at three years, compared with 67% of those receiving standard chemotherapy.
The combination of Calquence and venetoclax, developed by AbbVie and Genentech, is already approved in the European Union, Canada and the UK, with further regulatory reviews ongoing in other countries.
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