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
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.
- 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. https://bit.ly/2PucvEW. Accessed December 16, 2019.
- 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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