Oncomine Dx Target Test 获批，作为Ivosidenib治疗IDH1+胆管癌患者的伴随诊断

Author: Medicalhalo

Release time: 2025-10-19 11:44:20

Companion diagnostics that prescribe appropriate medicines can accurately determine whether cancer patients are suitable for certain drug treatments, bringing hope to cancer patients.

ThermoFisher Scientific said the Oncomine Dx Target Test has received premarket approval as a companion diagnostic to identify patients with IDH1-mutated cholangiocarcinoma who are suitable for treatment with ivosidenib (Tibsovo).

(Source: Internet)

On August 25, 2021, the FDA approved ivosidenib for the treatment of adult patients with IDH1-positive cholangiocarcinoma, becoming the first treatment drug approved for this type of patients. At the same time, ivosidenib is also used to treat newly diagnosed patients with IDH1-positive acute myeloid leukemia (age 75 and above or who are not suitable for chemotherapy).

Ivosidenib was approved to treat patients with IDH1-mutant cholangiocarcinoma based on results from the Phase 3 ClarIDHy trial (NCT02989857). The study found that ivosidenib provided 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.

"Previously, there were no approved targeted treatment options for this patient population," said Dr. Susan Pandya, vice president of clinical development at Servier Pharmaceuticals. "The FDA's approval of ivosidenib for the treatment of patients with IDH1 cholangiocarcinoma is an important milestone for the cholangiocarcinoma community."

The IDH1 gene is commonly associated with cholangiocarcinoma, and next-generation sequencing (NGS)-based testing has been shown to produce significant, reproducible results for the IDH1 gene. In 2017, Oncomine Dx Target Test received its first approval and is currently used as a companion diagnostic treatment for 4 targeted therapies for non-small cell lung cancer and 1 targeted therapy for cholangiocarcinoma.

In addition, a commercial development agreement has been reached to use the Oncomine Dx Target Test in conjunction with the Oncomine Precision Assay to identify patients with IDH1/2-positive low-grade glioma who may benefit from treatment with vorasidenib (AG-881).

Reference materials: 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

[ Disclaimer ] The content on this page comes from public channels (such as FDA official website, Drugs official website, original pharmaceutical manufacturer official website, etc.). It is only used for medical and pharmaceutical research reference by personnel with medical professional qualifications and does not constitute any treatment advice or drug recommendation. The drugs involved may not have been approved for marketing in mainland China and are not suitable for sale and use in China. If you need treatment, please consult a regular medical institution. This site does not provide drug sales or purchasing services.

[ 免责声明 ] 本页面内容来自公开渠道（如FDA官网、Drugs官网、原研药厂官网等），仅供持有医疗专业资质的人员用于医学药学研究参考，不构成任何治疗建议或药品推荐。所涉药品可能未在中国大陆获批上市，不适用于中国境内销售和使用。如需治疗，请咨询正规医疗机构。本站不提供药品销售或代购服务。

上一篇： FDA授予Gavocabtagene autoleuel孤儿药称号，用于治疗胆管癌

下一篇： IDH1突变型胆管癌精准疗法，艾伏尼布获批上市！

Menu

Oncomine Dx Target Test 获批，作为Ivosidenib治疗IDH1+胆管癌患者的伴随诊断

Category

相关知识