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# Fast Track for Colorectal Cancer Folate Drug
- URL: https://www.fdaweb.com/fast-track-for-colorectal-cancer-folate-drug/
- Published: 2021-11-23T12:00:00.000Z
- Updated: 2026-09-14T17:23:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150637

FDA has granted Isofol Medical a fast track designation for arfolitixorin, a stabilized and biologically active pure form of folate (\[6R\]-MTHF) for treating patients with metastatic colorectal cancer. Arfolitixorin is designed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. It is currently being studied in the pivotal Phase 3 AGENT study. “As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective,” the company says.  

Isofol says the AGENT study is assessing the efficacy and safety of arfolitixorin compared to leucovorin, both used in combination with 5-FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. The primary endpoint is overall response rate, and key secondary endpoints are progression free survival and duration of response.