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FDA Grants Breakthrough Designation to Ivosidenib Combo for Newly Diagnosed IDH1+ AML

Gina Columbus @ginacolumbusonc
Published: Wednesday, Mar 27, 2019

Dr. Chris Bowden

Chris Bowden, MD
The FDA has granted a breakthrough therapy designation to the combination of ivosidenib (Tibsovo) and azacitidine for the treatment of newly diagnosed patients with IDH1-mutant acute myeloid leukemia (AML) ≥75 years old or are ineligible for intensive induction chemotherapy.

mutations in July 2018.

References

  1. Agios Receives FDA Breakthrough Therapy Designation for TIBSOVO® (ivosidenib) in Combination with Azacitidine for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) with an IDH1 Mutation in Adult Patients Ineligible for Intensive Chemotherapy. Agios Pharmaceuticals. Published March 27, 2019. https://bit.ly/2FB4Uyt. Accessed March 27, 2019.
  2. Agios Reports Updated Data from Phase 1 Study of Ivosidenib in Combination with Azacitidine Demonstrating Deep and Durable Responses in Newly Diagnosed IDH1 Mutant Acute Myeloid Leukemia (AML) Patients. Agios Pharmaceuticals. Published February 25, 2019. https://bit.ly/2JHCjwt. Accessed February 25, 2019.

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