NEW YORK – The US Food and Drug Administration has accepted Servier's supplemental new drug application seeking approval for Tibsovo (ivosidenib) as a treatment for patients with relapsed or refractory IDH1-mutated myelodysplastic syndromes.
Servier's application includes data from a pivotal Phase I study in which 38.9 percent of myelodysplastic syndrome patients experienced a complete response on the IDH1 inhibitor. The objective response rate was 83.3 percent.
The FDA has granted priority review to Servier's application, which means the agency is slated to issue a decision within six months, or by February 2024. The agency has also deemed Tibsovo a breakthrough therapy in this setting.
"While the novel use of targeted IDH inhibition has been proven across a number of difficult-to-treat cancers, there continues to be a significant unmet need for myelodysplastic syndrome patients within this molecularly defined subset, especially those who experience disease progression," Amir Fathi, director of Massachusetts General Hospital's Center for Leukemia, said in a statement. "Today's filing acceptance provides further support for the potential efficacy and acceptable safety profile of Tibsovo in relapsed or refractory MDS and reinforces the importance of mutation testing in this patient population."
The FDA has previously approved Tibsovo either alone or with chemotherapy for treating newly diagnosed IDH1-mutated acute myeloid leukemia as well as for relapsed or refractory IDH1-mutated AML and relapsed or refractory IDH1-mutated cholangiocarcinoma. European regulators have also approved the drug as an AML and cholangiocarcinoma therapy.