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Roche: FDA Approves Venclexta Combinations For Treatment Of Acute Myeloid Leukaemia

Roche (RHHBY) announced the FDA has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was granted provisional approval under the accelerated approval programme in November 2018.

Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, in the US, and commercialised by AbbVie, under the brand name Venclyxto outside of the US.

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