全球首个用于治疗IDH1突变胆管癌的药物-艾伏尼布

On August 26, 2021, news came from overseas about ivosidenib, the precision treatment drug of CStone Pharmaceuticals, an innovative pharmaceutical company. The drug has successfully obtained FDA approval for previously treated adult patients with locally advanced or metastatic cholangiocarcinoma who carry IDH1 mutations detected by FDA-approved testing methods. This news means that it has become the first drug in the world to be approved by the US FDA for targeted treatment of patients with IDH1-mutated cholangiocarcinoma.

Data from a phase 3 clinical trial called ClarIDHy directly led to ivonib being granted priority review status by the FDA. This study is the world's first randomized phase 3 clinical trial for previously treated cholangiocarcinoma patients carrying IDH1 mutations. The trial results showed that compared with the placebo group, the ivonib treatment group achieved the primary endpoint of progression-free survival (PFS) and greatly reduced the patient's risk of disease progression or death. At the same time, ivonib also improved the overall survival (OS) of patients.

The prescribing information for this product includes a boxed warning that this product may cause a serious adverse reaction called differentiation syndrome, which can be fatal. Differentiation syndrome may present with symptoms including fever, dyspnea, acute respiratory distress, pulmonary inflammation, pleural or pericardial effusion, rapid weight gain, liver, kidney or multiple organ dysfunction. When the above symptoms are suspected, doctors can treat them with corticosteroids and observe the patient closely until the symptoms disappear. Other serious warnings include the potential for prolongation of the QT interval, which is life-threatening for patients, so an electrocardiogram should be performed during treatment; neurological monitoring should also be performed to avoid the development of Guillain-Barré syndrome.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.