The FDA approved ivosidenib (Tibsovo, Servier) for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
The agency also approved the Oncomine Dx Target Test (Life Technologies) as a companion diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib.
"Patients living with IDH1-mutated cholangiocarcinoma, especially those whose disease