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Home » FDA Approves First Targeted Treatment for Relapsed or Refractory AML
FDA Approves First Targeted Treatment for Relapsed or Refractory AML
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July 23, 2018
The FDA cleared Agios Pharmaceuticals’ Tibsovo (ivosidenib) as the first targeted treatment for patients with relapsed or refractory acute myeloid leukemia with a certain mutation.
The treatment is approved for use with a companion Abbott Laboratories diagnostic to detect specific mutations in the IDH1 gene. The agency based the approval on a single-arm, 174-patient trial.
The drug must be dispensed with a patient medication guide and will include a boxed warning about the potential for an adverse reaction known as differentiation syndrome.
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