FDA grants priority review to Tibsovo for cholangiocarcinoma
The FDA granted priority review to ivosidenib tablets for patients with previously treated IDH1-mutated cholangiocarcinoma, according to the agent’s manufacturer.
Cholangiocarcinoma is an aggressive cancer of the bile ducts. Approximately 13% of patients with cholangiocarcinoma harbor IDH1 mutations.
The FDA previously approved ivosidenib tablets (Tibsovo, Servier Pharmaceuticals) as monotherapy for adults with IDH-1 mutant relapsed or refractory acute myeloid leukemia, as well as for adults with newly diagnosed IDH1-mutant AML who either are aged 75 years or older or have comorbidities that preclude them from undergoing intensive induction chemotherapy.
A supplemental new drug application for the cholangiocarcinoma indication is based on results of the randomized phase 3 ClarIDHy study.
As Healio previously reported, results presented at Gastrointestinal Cancers Symposium showed ivosidenib extended OS compared with placebo among patients with previously treated IDH-1 mutated advanced cholangiocarcinoma. The agent also appeared well-tolerated.
"There are no approved systemic therapies for IDH1-mutated cholangiocarcinoma and limited chemotherapy options are available for patients with advanced disease," Susan Pandya, MD, vice president for clinical development and head of cancer metabolism global development at Servier Pharmaceuticals, said in a company-issued press release. “The FDA's priority review is a major milestone for patients.”