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.
