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FDA Grants Ivosidenib Priority Review for Frontline IDH1+ AML

Jason M. Broderick @jasoncology
Published: Wednesday, Feb 20, 2019

Dr. Chris Bowden

Chris Bowden, MD
The FDA has granted a priority review to a supplemental new drug application (sNDA) for ivosidenib (Tibsovo) for the frontline treatment of patients IDH1-mutant acute myeloid leukemia (AML) who are ineligible for standard chemotherapy.

-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 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.
  2. 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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