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Marketing authorization with orphan designation - USA

  • Tradename: TIBSOVO
  • ATC code : L01XX62
  • EU Number: -
  • MA date : 20/07/2018
  • MA holder: AGIOS PHARMACEUTICALS, INC.

Therapeutic indication

* Treatment of newly-diagnosed acute myeloid leukemia(AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
* Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Diseases list

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