publication date: Oct. 23, 2020

Drugs & Targets

Venclexta combination receives FDA approval for untreated AML

Venclexta (venetoclax) has received FDA approval in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for newly-diagnosed acute myeloid leukemia in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.

Venclexta is sponsored by AbbVie Inc. and Genentech Inc. Venetoclax was initially granted accelerated approval for this indication in November 2018.

Efficacy was confirmed in two randomized, double-blind, placebo-controlled trials in patients with AML described above.

In VIALE-A (NCT02993523), patients were randomized to receive venetoclax plus azacitidine (n=286) or placebo plus azacitidine (n=145). Efficacy was established based on an improvement in overall survival. The median OS was 14.7 months (95% CI: 11.9, 18.7) in patients treated with venetoclax plus azacitidine compared to 9.6 months (95% CI: 7.4, 12.7) in those receiving placebo plus azacitidine (HR 0.66; 95% CI: 0.52, 0.85; p<0.001). Patients treated with venetoclax plus azacitidine also demonstrated an improvement in complete remission rate: 37% (95% CI: 31%, 43%) versus 18% (95% CI: 12%, 25%).

In VIALE-C (NCT03069352), patients were randomized to receive venetoclax plus LDAC (n=143) or placebo plus LDAC (n=68). Efficacy was based on CR rate and duration of CR. The CR rate on the venetoclax plus LDAC arm was 27% (95% CI: 20%, 35%) with a median duration of 11.1 months (95% CI: 6.1, not reached) compared to 7.4% (95% CI: 2.4%, 16%) with a median duration of 8.3 months (95% CI: 3.1, not reached) in those receiving placebo plus LDAC. Venetoclax plus LDAC did not significantly improve OS versus placebo plus LDAC (HR 0.75; 95% CI 0.52, 1.07; p=0.114).

This review was conducted under Project Orbis and used … Continue reading Venclexta combination receives FDA approval for untreated AML

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