TIBSOVO

批准信原文要点

This Prior Approval supplemental new drug application provides for a new indication for TIBSOVO for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

批准信原文要点

TIBSOVO is indicated in combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

批准信原文要点

This Prior Approval supplemental new drug application proposes a new indication for Tibsovo (ivosidenib) for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following changes: • Revised carton labeling to change the country of origin statement from “Made in Portugal” to “Product of Portugal” • Revised container labeling to remove the country of origin statement “Made in Portugal”

批准信原文要点

This Prior Approval supplemental new drug application provides for carton labeling for TIBSOVO to contain the 60-count bottle of 250 mg ivosidenib tablets (NDC 71334-100 01).

批准信原文要点

This Prior Approval supplemental new drug application provides for the use of Tibsovo® (ivosidenib) tablets for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.