In May, the FDA granted priority review to the IDH1 inhibitor ivosidenib. Then, on August 25, 2021, the FDA approved the drug for use in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by an FDA-approved test.
After recently granting ivosidenib priority review status, the FDA wasted no time in approving the IDH1 inhibitor for use in cholangiocarcinoma just weeks later.
A priority review usually means the FDA will review a drug within 6 months, instead of 10 months with a standard review. But considering the success of ivosidenib in clinical trials, it’s no surprise this drug was approved in half the time. And with liver cancer and cholangiocarcinoma predicted to be the third leading cause of cancer death by 2040, this news brings hope twice as fast to those who need it most.
Ivosidenib was investigated in a randomized, multicenter, double-blind, placebo-controlled Phase 3 clinical trial – Study AG120-C-005. The 185 participants were adults with locally advanced or metastatic IDH1-mutant cholangiocarcinoma, whose disease must have progressed following at least one, but not more than two, prior treatments, including at least one gemcitabine or 5-flurouracil based chemotherapy regimen.
The Rare Initiative’s Dr. Lipika Goyal has been working alongside Servier Pharmaceuticals to develop ivosidenib. Bill Cance, Chief Medical and Scientific Officer at the American Cancer Society, took to Twitter to praise the game-changing oncologist for her role in bringing another treatment option to those with the most limited options and the least hope.