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FDA Approves Ivosidenib for Frontline IDH1+ AML

Gina Columbus @ginacolumbusonc
Published: Thursday, May 02, 2019

The FDA has approved a supplemental new drug application (sNDA) for ivosidenib (Tibsovo) as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia (AML), as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.1

-positive relapsed/refractory AML. In the study, the CR rate was 24.7% (95% CI, 18.5-31.8) and the CRh rate was 8% (95% CI, 4.5-13.1). The median duration of CR plus CRh was 8.2 months (range, 5.6-12). Among the CR/CRh population, the median time to best response was 2.0 months (range, 0.9-5.6).

References

  1. Agios Announces FDA Approval of Supplemental New Drug Application (sNDA) for TIBSOVO® as Monotherapy for Newly Diagnosed Adult Patients with IDH1 Mutant Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy. Agios. Published May 2, 2019. https://bit.ly/2DNjOkV. Accessed May 2, 2019.
  2. Agios Presents Updated Data from the Ivosidenib Phase 1 Dose-Escalation and Expansion Trial in IDH1 Mutant Positive Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible for Standard Treatment and Myelodysplastic Syndrome (MDS). Agios. Published December 3, 2018. Accessed February 20, 2019. https://bit.ly/2Gydl0p.
  3. FDA Grants Approval of TIBSOVO®, the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation. Agios. Published July 20, 2018. Accessed February 20, 2019. https://bit.ly/2mwqScv.

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