FDA approves Servier Pharmaceuticals’ new MDS therapy
The US Food and Drug Administration (FDA) has announced that it has approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation. This approval makes the drug the first targeted therapy for this indication.
The FDA has also approved the Abbott RealTime IDH1 Assay as a companion diagnostic test for this indication.
Tibsovo has previously been approved for some adult patients with newly-diagnosed Acute Myeloid Leukaemia (AML), R/R AML and locally advanced or metastatic cholangiocarcinoma.
The effectiveness of the drug for this indication has been assessed in an open-label, single-arm, multicentre study of 18 adult patients with R/R MDS with the IDH1 mutation. The drug has a complete remission or partial remission rate of 39%, with all observed responses being complete remissions.
Common side effects included diarrhoea, constipation, nausea, joint pain, fatigue, cough, muscle aches and rashes.
Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, commented: “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.”
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