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On May 25, 2021, the European Commission approved venetoclax with a hypomethylating agent for adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Venetoclax is a first-in-class B-cell lymphoma-2 (BCL-2) selective inhibitor that promotes leukemic cell apoptosis, and it is administered in combination with azacitidine, decitabine, or low‑dose cytarabine. The approval was based on results from the placebo-controlled phase III VIALE‑A trial (NCT02993523), which showed that patients treated with venetoclax in combination with azacitidine demonstrated significant improvements in overall survival. The approval was also based on results of the phase Ib M14-358 trial (NCT02203773), in which patients treated with venetoclax and azacitidine/decitabine achieved high remission rates.
This European Commission approval is valid in all 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway. It follows the positive opinion received from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use and the approval by the U.S. Food and Drug Administration (FDA).
Patients with newly diagnosed AML who are ineligible or do not respond well to induction chemotherapy due to advanced age, comorbidities, or IDH1/2 mutations have poor outcomes and reduced therapeutic options available. Therefore, this new regimen provides a safe and efficacious alternative in this setting.
Venetoclax for the treatment of AML: Developments and progress in 2020
Venetoclax (Ven) was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia in January, 2016. Since then, it has...
Venetoclax plus hypomethylating agents for the treatment of chemotherapy-ineligible or high-risk AML
Patients with newly diagnosed acute myeloid leukemia who are ineligible or do not respond well to intensive chemotherapy have poor outcomes and...
EMA CHMP grants positive opinion for venetoclax in combination with hypomethylating agents for the treatment of patients with newly diagnosed AML
On April 23, 2021, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use...
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