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# FDA OKs Expanded Tibsovo Indication Plus Diagnostic Test
- URL: https://www.fdaweb.com/fda-oks-expanded-tibsovo-indication-plus-diagnostic-test/
- Published: 2021-08-26T12:00:00.000Z
- Updated: 2026-09-14T17:12:03.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5150023

FDA has approved a Servier Pharmaceuticals sNDA expanding the indication of Tibsovo (ivosidenib tablets) to treat adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-approved test. At the same time, the agency gave premarket [approval](https://www.marketwatch.com/press-release/fda-approves-ngs-based-companion-diagnostic-for-previously-treated-idh1-mutated-cholangiocarcinoma-2021-08-25?tesla=y&ref=fdaweb.com) to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to identify patients with IDH1 mutated cholangiocarcinoma who may be candidates for Tibsovo.

Servier [says](https://www.marketwatch.com/press-release/servier-announces-fda-approval-of-tibsovo-ivosidenib-tablets-in-idh1-mutated-cholangiocarcinoma-2021-08-25?tesla=y&ref=fdaweb.com) the sNDA received priority review and was based on data from the ClarIDHy study, the only randomized Phase 3 trial for previously treated IDH1-mutated cholangiocarcinoma.

Tibsovo also is approved in the U.S. as monotherapy for treating adults with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutated AML who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy.