Olutasidenib & Acute myeloid leukemia (AML) (IDH1 m)

Approval Status

Olutasidenib is approved by the FDA for treating Acute myeloid leukemia (AML) (IDH1 m). It is approved as a monotherapy for adults with relapsed or refractory AML, using an FDA-approved test to detect the mutation. The approval is based on a pivotal phase 2 cohort, with a labeled dose of 150 mg twice daily.

Olutasidenib does not have EMA marketing authorization for AML. It has an orphan designation for AML treatment granted in 2019, indicating it was not authorized in the EU at the time of submission. There is also an EMA pediatric investigation plan for olutasidenib in AML, which supports regulatory development but does not equate…