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Roche: full FDA approval for Venclexta

( - Roche announces that the FDA has fully approved its Venclexta (venetoclax) in combination with azacitidine or decitabine, or low-dose cytarabine, for the treatment of acute myeloid leukaemia in patients aged 75 years and above, or who have a comorbidity that prohibits the use of intensive induction chemotherapy.

This decision is based on data from confirmatory phase III tests. Venclexta previously received an interim authorisation in this indication under the FDA's accelerated approval program in November 2018.

Jointly developed by AbbVie and Roche, Venclexta is jointly marketed by AbbVie and Genentech, a US subsidiary of Roche, in the United States, and by AbbVie alone, under the name of Venclyxto, in the rest of the world.

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