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VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML)

Published: 2020-10-16 23:34:00 ET

- The FDA approval of VENCLEXTA for newly-diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from a series of trials including two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043)

- The Phase 3 VIALE-A trial showed that significantly more patients treated with VENCLEXTA in combination with azacitidine achieved complete remission and lived longer versus patients treated with azacitidine alone1

- AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate2,3

- The National Comprehensive Cancer Network (NCCN) guidelines recommend the VENCLEXTA and azacitidine combination as a Category 1 Preferred AML treatment regimen for patients ineligible for intensive chemotherapy4

NORTH CHICAGO, Ill., Oct. 16, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has provided full approval to 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 who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. The approval is supported by data from the Phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies and updated data from the Phase 1b M14-358 and the Phase 1/2 M14-387 studies. The FDA previously granted accelerated approval to VENCLEXTA for this indication in 2018.5

"AML is a complex and challenging disease with generally low survival rates. This approval is significant because data from our VIALE-A trial has shown that newly-diagnosed patients, who cannot undergo intensive chemotherapy, lived longer when treated with VENCLEXTA plus azacitidine than those treated with azacitidine alone," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology development, AbbVie. "This trial also provides physicians more information for managing patients - from treatment initiation, to assessing response and management post disease remission."

Positive overall survival (OS) data seen at an interim analysis of the VIALE-A trial led to an early submission supporting the FDA approval of VENCLEXTA in AML. The trial showed patients on the active regimen of VENCLEXTA plus azacitidine achieved a 34% reduction in the risk of death compared to azacitidine in combination with placebo (Hazard Ratio [HR]=0.66 [95% CI: 0.52-0.85], p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.