AstraZeneca Says US FDA Approves Calquence Combo for Certain Blood Cancer Patients

MT Newswires Live02-20 20:39

AstraZeneca (AZN) said Friday that the US Food and Drug Administration approved Calquence, or acalabrutinib, plus venetoclax as the first all-oral, fixed-duration treatment for adults with chronic lymphocytic leukemia and small lymphocytic lymphoma.

The decision was based on the phase 3 Amplify trial, in which 77% of patients on the combination were progression-free at three years, versus 67% with standard-of-care chemotherapy, the company said.

The 14-month regimen offers an alternative to continuous therapies and may influence first-line treatment decisions, AstraZeneca said.

The combination is already approved in the European Union, Canada and the UK, with additional regulatory reviews ongoing.

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