Genentech/Roche files sNDA at the FDA for Venclexta in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC),to treat people with previously untreated acute myeloid leukemia (AML).
- Genentech, a member of the Roche Group announced submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax), in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC), for treatment of people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
The submission is based on the results of two Phase Ib/II studies that evaluated Venclexta in combination with azacitidine or decitabine (M14-358 study) or LDAC (M14-387 study) in this patient population. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and commercialized by AbbVie outside of the U.S.
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