LONDON (dpa-AFX) - AstraZeneca said a fixed-duration regimen of Calquence in combination with venetoclax, with or without obinutuzumab, has been approved in the European Union for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on results from the AMPLIFY Phase III trial.
AstraZeneca noted that regulatory applications for these regimens are currently under review in several countries based on the AMPLIFY results.
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