Abbott Realtime News Today

Ivosidenib monotherapy is now approved by the FDA for patients with relapsed/refractory myelodysplastic syndrome with an IDH1 mutation.

The FDA approval was based on a small study, in which 38.9% of patients with relapsed or refractory disease went into complete remission.

The FDA has approved Tibsovo (ivosidenib) for the treatment of adults with relapsed or refractory MDS with a susceptible IDH1 mutation.

/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory...

The Food and Drug Administration approved Tibsovo for patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation.

The FDA has approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes with a susceptible IDH1 mutation, as detected by an FDA-approved test.

The FDA approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes with an isocitrate dehydrogenase-1 mutation. The FDA also approved the Abbott RealTime IDH1 Assay as a companion diagnostic for the selection of patients.

The FDA has approved Rezlidhia (olutasidenib) to treat patients with IDH1-mutated, relapsed or refractory acute myeloid leukemia.

The FDA has approved Rezlidhia (olutasidenib) for acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.

The drug has been approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.