FDA Approval Insights: Ivosidenib in R/R IDH1+ Myelodysplastic Syndrome

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Courtney D. DiNardo, MD, MSCE, about the FDA approval of ivosidenib (Tibsovo) for patients with relapsed/refractory IDH1-mutant myelodysplastic syndromes (MDS). Dr DiNardo is an associate professor in the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.

On October 24, 2023, the FDA approved ivosidenib for adult patients with relapsed/refractory MDS with a susceptible IDH1 mutation. This regulatory decision was supported by findings from the single-arm, phase 1 AG120-C-001 trial (NCT02074839), in which ivosidenib elicited a complete response (CR) rate of 38.9% (95% CI, 17.3%-64.3%) and a median time to CR of 1.9 months (range, 1.0-5.6). The median duration of CR was not estimable (range, 1.9-80.8+).

In our exclusive interview, Dr DiNardo discussed the significance of this approval, the unique mechanism of action of ivosidenib, and key efficacy and safety findings from the AG120-C-001 trial.

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