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genentech

FDA fully approved Venclexta combinations for acute myeloid leukaemia

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The FINANCIAL — Roche today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this setting under the FDA’s accelerated approval programme in November 2018. Today’s FDA approval converts Venclexta’s accelerated approval in this setting to a full approval. “Today’s full approval is supported by the significant results that showed…

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FDA fully approved Venclexta combinations for acute myeloid leukaemia

2 mins read

The FINANCIAL — Roche today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive…