BCL-2 inhibitor Venetoclax is fully approved by the FDA for the treatment of acute myeloid leukemia (AML)

Recently, the FDA has approved a combination of Venetoclax with azatsin, tesitalbin, or low-dose LDAC for the treatment of patients over 75 years of age with acute myeloid leukemia (AML), who are not suitable for intensive induction chemotherapy.
AbbVie said data from phase III VIALE-A and VIALE-C trials supported the full approval.
VIALE-A study assessed the total survival rate (OS) of 431 AML patients who were not suitable for standard-induced chemotherapy, who were randomly assigned to venclexta combined azatide or placebo combined azaside therapy.
results showed that the risk of death was reduced by 34% compared to the combined placebo of Azaxta, with a medium OS of 14.7 months in patients treated with Venclexta and 9.6 months in the placebo group.
addition, the rate of complete remission (CR) was 37 per cent for patients treated with Venclexta, 18 per cent for CR and 13.4 months for CR in the placebo group.
viaLE-A results were presented at this year's Virtual Conference of the European Society of Hematology (EHA) and were recently presented at NEJM.
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