5 May 2021 - Servier Pharmaceuticals today announced that the U.S. FDA has accepted the company's supplemental new drug application for Tibsovo (ivosidenib) as a potential treatment for patients with previously treated IDH1 mutated cholangiocarcinoma.
The supplemental new drug application is supported by data from the ClarIDHy study, the first and only randomised Phase 3 trial for previously treated IDH1 mutated cholangiocarcinoma.