IDH1 mutation rate is high, accounting for 13% of all cholangiocarcinoma patients. Currently, treatments for patients with IDH1-mutated cholangiocarcinoma are limited, and there are no approved treatment options. ivosidenib (ivosidenib) was approved and became a beneficial "weapon" for this type of patients!
Servier Pharmaceuticals announced that the FDA has approved oral ivosidenib (Tibsovo) for the treatment of adult patients with IDH1-mutated cholangiocarcinoma as determined by an FDA-approved test.
The approval was based on results from the Phase 3 ClarIDHy trial (NCT02989857), in which ivosidenib demonstrated a statistically significant improvement in progression-free survival. Median progression-free survival (PFS) was 2.7 months in the ivosidenib group and 1.4 months in the placebo group. Overall, 32% of patients receiving ivosidenib did not experience disease progression or death at 6 months and 22% at 12 months.
The study protocol allowed patients receiving placebo to cross over to receive ivosidenib as their disease progressed. A total of 70.5% of patients crossed over to receive ivosidenib. Not only did the primary endpoint of improvement in PFS be achieved, the key secondary endpoint of the study, overall survival (OS), was also significantly improved. Among patients without crossover, median overall survival was 10.3 months in the ivosidenib group and 7.5 months in the placebo group.
The most common adverse reactions include: fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash.
Dr. Rachna T. Shroff, associate professor of medicine at the University of Arizona, said: "Patients with IDH1-mutant cholangiocarcinoma, especially those whose disease progresses after chemotherapy, urgently need new treatment options. Ivosidenib has a good safety profile and significantly improves the progression-free survival of patients, and will become a new option for this type of patients."
The FDA also granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic to identify patients with IDH1-mutant cholangiocarcinoma who are eligible for treatment with ivosidenib.
On May 5, 2021, the FDA granted Ivosidenib's new drug application priority review status, speeding up the review. Now, Ivosidenib has been approved for marketing and has become an important option for patients with IDH1 mutant cholangiocarcinoma.
References: FDA instructions were updated on October 24, 2023. FDA instructions website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&ApplNo=211192
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