NEW YORK – The US Food and Drug Administration on Tuesday approved Servier's Tibsovo (ivosidenib) for patients with relapsed or refractory myelodysplastic syndromes (MDS) whose cancers harbor IDH1 mutations.
In tandem, the FDA approved Abbott Diagnostics' RealTime IDH1 Assay as a companion diagnostic to screen patients for Tibsovo eligibility.
The approval, which comes on the heels of the FDA granting Servier priority review when the drugmaker filed its application in August, is based on the results of a Phase I clinical trial. In that trial, 83.3 percent of patients with IDH1-mutated MDS responded to treatment with Tibsovo, and 38.9 percent experienced a complete response. At the time of the data cutoff, patients on the trial had a median overall survival of 35.7 months.
The Tibsovo approval marks the first targeted therapy approved for this molecularly defined population of MDS patients, according to Servier. Tibsovo already has FDA approval, either alone or with chemotherapy, for newly diagnosed IDH1-mutated acute myeloid leukemia. It is also approved for relapsed or refractory IDH1-mutated AML and relapsed or refractory IDH1-mutated bile duct cancers. In Europe, the drug also has AML and cholangiocarcinoma approval.