October 26, 2023- The U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 Assay as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation.
This is the first targeted therapy approved for this indication. MDS are a rare form of blood cancers that can occur when the mutations in the bone marrow progenitor cells (cells that form blood) lead to insufficient numbers of healthy blood cells. Approximately 60,000 to 170,000 people live with MDS in the U.S., with an estimated 87,000 new cases each year worldwide. About 3.6 percent of patients with MDS have an IDH1 mutation.