The Food and Drug Administration (FDA) recently approved Venclexta (venetoclax) as part of a non-chemotherapy 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.
Don A. Stevens, M.D., an oncologist at Norton Cancer Institute, was a pivotal investigator in this treatment’s clinical trial, enrolling Louisville-area patients living with AML.
The trial examined using Venclexta in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC). The full approval for this use of Venclexta follows the FDA’s November 2018 grant of provisional approval.
The approval is based primarily on the results of two Phase 3 studies, including one published in the New England Journal of Medicine in August 2020. The studies showed Venclexta plus azacitidine significantly reduced the risk of death by 34% compared with azacitidine alone.
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Dr. Stevens’ current clinical trials and studies
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