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FDA grants third breakthrough therapy designation to venetoclax
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The FDA granted breakthrough therapy designation to venetoclax in combination with hypomethylating agents for the treatment of patients with untreated acute myeloid leukemia who are ineligible to receive standard induction therapy with high-dose chemotherapy, according to a press release from the drug’s manufacturer.
Venetoclax (AbbVie and Genentech/Roche), an inhibitor of the B-cell lymphoma-2 protein, previously received FDA breakthrough therapy designation for the single-agent treatment of patients with relapsed or refractory chronic lymphocytic leukemia who harbor the 17p deletion genetic alteration, as well as for treatment in combination with rituximab (Rituxan; Genentech, Biogen Idec) for patients with relapsed/refractory CLL.
The most recent designation is based on data from one study that included patients aged 65 years or older with untreated AML.
“Acute myeloid leukemia is an aggressive and life-threatening cancer. Unfortunately, for many AML patients, intensive therapy is not an option, causing a high need for new, effective and alternative treatments," Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in the release. “This third breakthrough therapy designation for venetoclax highlights our efforts to pursue the significant and broad potential of this therapy.”