Roche and AbbVie have won FDA approval of Venclexta (venetoclax) in combination with the chemotherapy drugs azacytidine, decitabine or low-dose cytarabine for the treatment of acute myeloid leukemia in adults aged 75 or older, or those unable to undergo intensive chemotherapy.

Venclexta is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

The approval was supported by data from a phase 3 study demonstrating Venclexta and azacytidine reduced mortality by 34 percent vs. azacytidine by itself. In addition, patients receiving Venclexta plus azacitidine saw almost 20 percent higher complete remission rates.

In another phase 3 study, 27 percent of patients receiving Venclexta and low-dose cytarabine combined saw complete remission at 11 months compared with 7.4 percent of patients who took low-dose cytarabine alone. There was no trial data released for decitabine.

The approval was granted under Project Orbis, which enables concurrent reviews by the FDA and health authorities of Australia, Canada and Singapore.