The US Food and Drug Administration (FDA) has granted approval for Servier’s Tibsovo (ivosidenib tablets) to treat isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS), a rare blood cancer.
This development marks the fifth indication for Tibsovo for IDH1-mutated cancers.
It is the only targeted treatment to obtain approval for IDH1-mutated R/R MDS.
The new approval is based on data from an open-label Phase I clinical trial that assessed the tolerability, clinical activity and safety of ivosidenib.
Findings showed that treatment with Tibsovo offered a 38.9% complete remission rate (CR) and an 83.3% objective response rate in trial subjects.
The median time to CR was 1.9 months. Adverse events linked to Tibsovo were in line with its already reported safety profile.
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Tibsovo received breakthrough therapy designation to treat adults with IDH1-mutated R/R MDS, and obtained priority review.
Servier Pharmaceuticals commercial head Arjun Prasad stated: “Servier is proud to lead the way in mutant IDH inhibition through continued innovations that support patients living with difficult and hard-to-treat cancers.
“As the first and only targeted therapy available for patients with IDH1-mutated relapsed or refractory myelodysplastic syndromes, the FDA approval for Tibsovo reinforces our commitment to deliver significant advances in areas of high unmet need and bring the right treatment, to the right patient, at the right time.”
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