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FDA Grants Ivosidenib Breakthrough Status for Relapsed/Refractory IDH1+ MDS

Gina Columbus @ginacolumbusonc
Published: Tuesday, Dec 17, 2019

Dr. Chris Bowden

Chris Bowden, MD
The FDA has granted a breakthrough therapy designation to ivosidenib (Tibsovo) for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes (MDS) who harbor IDH1 mutations.1

In October 2019, the MDS arm of patients was reopened, and investigators will enroll ≤25 patients to generate enough data for a potential regulatory filing for ivosidenib in this setting. Recruitment is ongoing in 22 sites in both the United States and France, Agios concluded in the press release.


  1. Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation [news release]. Agios Pharmaceuticals. Published December 16, 2019. Accessed December 16, 2019.
  2. Foran JM, DiNardo CD, Watts JM, et al. Ivosidenib (AG-120) in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome: updated enrollment of a phase 1 dose escalation and expansion study. Blood. 2019;134(suppl_1):4254. doi: 10.1182/blood-2019-123946.

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