Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib) in IDH1 mutated cholangiocarcinoma

Servier

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.

Read Servier Pharmaceuticals press release

Michael Wonder

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Michael Wonder