Roche and AbbVie apply to take Venclexta into AML treatment setting

12 July 2018

Switzerland’s Roche (ROG: SIX) and Chicago, USA-based AbbVie (NYSE: ABBV) have submitted to extend the US label for Venclexta (venetoclax) as a first-line acute myeloid leukemia (AML) therapy.

The application covers Venclexta in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC), for people who are ineligible for intensive chemotherapy.

The submission is based on the results of two Phase Ib/II studies that evaluated the combination in this patient population. AbbVie won Breakthrough Therapy designation from the US Food and Drug Administration for the drug in this indication at the start of 2016.

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