A month ahead of its Aug. 21 PDUFA date, Tibsovo (ivosidenib, formerly AG-120) received full FDA approval Friday to treat adults with relapsed or refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. The oral drug, developed by Agios Pharmaceuticals Inc., became the first FDA-approved therapy in the targeted indication and the first in the class green-lighted with an FDA-approved companion diagnostic, the Abbott Realtime IDH1 test.