BRIEF—Full FDA approval for myeloid leukemia drug Venclexta combo

The Food and Drug Administration 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 leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Venclexta is being developed by Genentech, a subsidiary of Swiss pharma giant Roche, and US drug major AbbVie.

It is jointly commercialized by the companies in the USA and by AbbVie alone outside of the USA.

Venclexta, which generated second-quarter 2020 sales of $303 million for AbbVie, was previously granted provisional approval in this setting under the FDA’s accelerated approval program in November 2018.

Today’s FDA approval converts Venclexta’s accelerated approval in this setting to a full approval.