FDA grants priority review to ivosidenib for certain patients with acute myeloid leukemia

The FDA granted priority review to ivosidenib tablets in combination with azacitidine for previously untreated IDH1-mutated acute myeloid leukemia.
Ivosidenib (Tibsovo, Servier) — an oral IDH1 inhibitor — is approved in the United States for treatment of adults with relapsed or refractory IDH1 mutation-positive AML, as well as for adults with newly diagnosed IDH1 mutation-positive AML who are aged 75 years or older or who are ineligible for intensive induction chemotherapy due to comorbidities.
The agent also is approved for adults with previously treated, locally advanced or

The FDA granted priority review to ivosidenib tablets in combination with azacitidine for previously untreated IDH1-mutated acute myeloid leukemia.
Ivosidenib (Tibsovo, Servier) — an oral IDH1 inhibitor — is approved in the United States for treatment of adults with relapsed or refractory IDH1 mutation-positive AML, as well as for adults with newly diagnosed IDH1 mutation-positive AML who are aged 75 years or older or who are ineligible for intensive induction chemotherapy due to comorbidities.
The agent also is approved for adults with previously treated, locally advanced or