Tibsovo sNDA receives FDA acceptance and Priority Review for IDH1-mutated cholangiocarcinoma

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has accepted the company’s supplemental New Drug Application for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously treated IDH1-mutated cholangiocarcinoma.

Tibsovo is sponsored by Servier Pharmaceuticals.

The sNDA was granted Priority Review, which accelerates the review time from 10 months to a goal of 6 months from the day of filing acceptance. 

The sNDA acceptance is supported by data from the ClarIDHy study, the first and only randomized phase III trial for previously treated IDH1-mutated cholangiocarcinoma. A presentation of the data will be presented at the American Society of Clinical Oncology annual meeting June 4-8.

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

Table of Contents

YOU MAY BE INTERESTED IN

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL). 
Over the past three decades, cancer genetics has transformed precision oncology. Germline testing has advanced from single-gene Sanger sequencing to parallel sequencing of hundreds of genes, while tumor (somatic) testing has expanded with the rise of targeted therapies based on point mutations, copy number changes and other alterations. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login