Agios’ Tibsovo (ivosidenib) Receives the US FDA’s Breakthrough Therapy Designation for Patients with Relapsed or Refractory Myelodysplastic Syndrome with an IDH1 Mutation

Agios Pharmaceuticals’ Tibsovo (ivosidenib) Receives Approval For R/R Acute Myeloid Leukemia (AML) and IDH1 Mutation

Shots:

  • The FDA’s BT designation is based on MDS arm of P-I dose-escalation and expansion study assessing Tibsovo (500mg) in 12 patients with r/r MDS with a susceptible IDH1 mutation as detected by an FDA-approved test
  • The P-I study results: median treatment duration (11.4mos.); as of Nov 02, 2018, patients showing response (75%); CR (42%); patients who have CR (60% remained relapse-free @12mos.); 75% were transfusion-independent for 56 days or longer
  • Tibsovo is an IDH1 inhibitor, indicated to treat adults with r/r AML with a susceptible IDH1 mutation as detected by an FDA-approved test

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