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However, the ClarIDHy trial did meet the primary endpoint of progression-free survival, based on which the firm will submit the drug for FDA approval in Q1 2021.
Chi-Med subsidiary Hutchison Medipharma has kicked off the Phase I trial in China and has dosed its first patient with the investigational IDH inhibitor.
Thermo will develop a test using its Oncomine Precision Assay to identify IDH1- and IDH2-positive low-grade glioma patients for treatment with Agios' vorasidenib.
Glioma patients experienced tumors shrinkage, and some AML patients had a complete remission that allowed them to proceed to curative treatment.
Agios plans to expand IDH1 inhibitor ivosidenib into chondrosarcoma and cholangiocarcinoma and explore the pan-IDH inhibitor vorasidenib in glioma.
Based on the strength of the data from the ClarIDHy trial, Agios Pharmaceuticals is aiming to submit for regulatory approval with the FDA by year end.
The researchers believe using cerebral spinal fluid will enable them to identify brain tumors with a higher sensitivity than with blood samples.
The researchers aim to offer the half-hour diagnostic assay for use during neurosurgery to help clinicians pursue the best treatment for patients with gliomas.