FDA Approves Servier’s Tibsovo for Bile Duct Cancer
The FDA approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for treatment of adults with previously treated, locally advanced or metastatic cholangiocarcinoma, a rare form of bile duct cancer.
The approval was supported by a 185-person phase 3 study which showed the drug improved progression free survival in patients receiving Tibsovo vs. placebo. Tibsovo, which works by inhibiting mutant IDH1 enzymes, was previously approved for treating acute myeloid leukemia patients with an IDH1 mutation.
Approximately 8,000 individuals in the U.S. are diagnosed with the disease every year.