The decision, which specifically applies to adults with relapsed or refractory (R/R) MDS with an IDH1 mutation, makes Tibsovo the first targeted therapy approved for this indication.
The US regulator has also approved the use of a companion diagnostic, the Abbott RealTime IDH1 Assay, to identify eligible MDS patients.
An estimated 16,000 people in the US are diagnosed with MDS every year, and approximately 3.6% have an IDH1 mutation. The prognosis for these patients has often been associated with worse overall outcomes and an increased risk of transformation to acute myeloid leukaemia (AML).
