The approval was based on the data from the Phase 1, multicentre study of IDH1-mutated R/R MDS patients in which Tibsovo showed a complete remission rate of 38.9% and objective response rate of 83.3%
Servier has received FDA approval for Tibsovo to treat myelodysplastic syndromes. (Credit: National Cancer Institute on Unsplash)
The US Food and Drug Administration (FDA) has granted approval for Servier’s Tibsovo (ivosidenib) to treat adult patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS).
Tibsovo is a precision medicine that targets IDH1 mutation. It is currently approved in five indications globally, including clearance in the US, European Union, China, and Australia.
The US health regulator has approved the drug for MDS patients detected by an FDA-approved test.
For this, the agency has authorised the Abbott RealTime IDH1 Assay as a companion diagnostic to identify R/R MDS patients having an IDH1 mutation.
The approval of the drug was based on the data from the Phase 1, open-label, single-arm, multicentre study involving 18 IDH1-mutated R/R MDS patients.
As per the results, the patients treated with Tibsovo showed a complete remission (CR) rate of 38.9%. The objective response rate (ORR) was 83.3%.
The median time to CR was documented at 1.9 months. The median duration of CR did not reach at the time of data cutoff and the median overall survival was 35.7 months.
In addition, out of the nine patients who needed transfusions of blood or platelets due to MDS at the starting of the trial, six became independent of transfusions after treatment with Tibsovo.
Servier, which is based in France, said that the overall treatment-related adverse events in the trial were found to be similar with the known safety profile of the precision medicine.
FDA’s Center for Drug Evaluation and Research Office of Oncologic Diseases acting director Richard Pazdur said: “Today’s approval represents an important treatment advancement for rare blood cancers, and more specifically, patients with relapsed or refractory MDS who have an IDH1 mutation.
“Through the FDA’s Oncology Center of Excellence Rare Cancers Program, we remain committed to promoting scientific innovation and advancing the development of safe and effective novel therapies to treat patients with rare cancers.”
Previously, Tibsovo received breakthrough therapy designation for the treatment of adult patients with R/R (MDS) with an IDH1 mutation and obtained priority review, which accelerated the review timeline.