FDA approves Tibsovo to treat bile duct cancer

Servier Pharmaceuticals has received the Food and Drug Administration’s blessing for a new indication of Tibsovo (ivosidenib tablets). The drug is now approved to treat adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test.

The medication is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma.

Cholangiocarcinoma is a rare, aggressive cancer of the bile ducts within and outside of the liver.

"Servier has been focused on exploring the significant potential of inhibiting mutant IDH enzymes as a novel approach to treating cancers with high unmet needs, including cholangiocarcinoma," said David Lee, Servier Pharmaceuticals CEO. "We are proud to bring to patients the first and only targeted therapy for previously treated IDH1-mutated cholangiocarcinoma. We are grateful to the patients, caregivers, investigators and study teams who made this achievement possible through their participation in the ClarIDHy clinical trial."

[Read more: Agios gets FDA green light for Tibovo for AML]

“Before today’s approval of Tibsovo, there were no approved targeted therapies available to cholangiocarcinoma patients harboring the IDH1 mutation, and limited chemotherapy options available to patients with advanced disease,” said Stacie Lindsey, founder and CEO of the Cholangiocarcinoma Foundation. “This approval brings new hope to the cholangiocarcinoma community and we are excited that this much-needed new therapeutic option is being made available to patients.”

Tibsovo also is approved as monotherapy for the treatment of adults with IDH1-mutated relapsed or refractory acute myeloid leukemia and for adults with newly diagnosed IDH1-mutated AML who are 75 years old or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.