Roche: Venclexta applies for approval in US

(CercleFinance.com) - Roche has announced that it has submitted an additional application for authorization of Venclexta to the US FDA, for people with previously untreated acute myeloid leukemia who cannot undertake intensive chemotherapy.


This application is based on the results of two phase Ib/II studies that have evaluated Venclexta in combination with azacitidine or decitabine (study M14-358) or LDAC (study M14-387) in this patient population.

Jointly developed by Roche and AbbVie, this product is marketed in the US by AbbVie and Genentech, Roche's US subsidiary, and by AbbVie alone outside the US.



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