Servier scores US approval for new Tibsovo indication

Servier Pharmaceuticals, the US subsidiary of French privately-held drugmaker Servier, has won approval for Tibsovo (ivosidenib) in cholangiocarcinoma, a rare and aggressive form of cancer.

The approval provides for use of Tibsovo as a second-line option against locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by an FDA-approved test.

The approval is a significant landmark in the company’s expansion into the US market, and into oncology, which began in 2018 with the $2.4 billion acquisition of Shire’s cancer drug business.