Dr. Winer Discusses the FDA Approval of Ivosidenib in AML

Eric Stephen Winer, MD
Published: Thursday, May 02, 2019



Eric Stephen Winer, MD, assistant professor of medicine, Harvard Medical School, Dana-Farber Cancer Institute, discusses the FDA approval of ivosidenib (Tibsovo) in acute myeloid leukemia (AML).

May 2, 2019, the FDA approved a supplemental new drug application (sNDA) for ivosidenib as monotherapy for the frontline treatment of adult patients with IDH1-mutant AML, as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy. Data from a phase I trial served as the basis for the approval. In the trial, ivosidenib induced a 28.6% (95% CI, 13.2-48.7) complete response (CR) rate and a CR plus CR with partial hematologic recovery (CRh) rate of 42.9% (95% CI, 24.5-62.8). The median durations of CR and CR+CRh were not estimable, and 41.7% (n = 5) of patients who achieved CR/CRh remain on ivosidenib as of the data cutoff.

This approval brings yet another targeted treatment option with significant benefit to patients with IDH1-mutant AML, says Winer.
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Eric Stephen Winer, MD, assistant professor of medicine, Harvard Medical School, Dana-Farber Cancer Institute, discusses the FDA approval of ivosidenib (Tibsovo) in acute myeloid leukemia (AML).

May 2, 2019, the FDA approved a supplemental new drug application (sNDA) for ivosidenib as monotherapy for the frontline treatment of adult patients with IDH1-mutant AML, as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy. Data from a phase I trial served as the basis for the approval. In the trial, ivosidenib induced a 28.6% (95% CI, 13.2-48.7) complete response (CR) rate and a CR plus CR with partial hematologic recovery (CRh) rate of 42.9% (95% CI, 24.5-62.8). The median durations of CR and CR+CRh were not estimable, and 41.7% (n = 5) of patients who achieved CR/CRh remain on ivosidenib as of the data cutoff.

This approval brings yet another targeted treatment option with significant benefit to patients with IDH1-mutant AML, says Winer.



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