Arfolitixorin Lands FDA Fast Track Designation for Advanced CRC


Results from the phase 3 AGENT study are awaited after the FDA granted fast track designation to arfolitixorin for advanced colorectal cancer treatment.

The FDA has granted fast track designation to arfolitixorin for treatment of patients with metastatic colorectal cancer (mCRC), according to a press release issued by Isofol Medical AB.1

Arfolitixorin is a stabilized and biologically active pure form of folate ([6R]-MTHF), which is designed to enhance the efficacy of standard of care chemotherapy for advanced CRC. What may set the agent apart from others is that it does not require complicated metabolic activation to become effective, making it a potential treatment option for all patients with advanced CRC.

“We are thrilled that the FDA has granted fast track designation to our lead candidate arfolitixorin. This serves as a strong external validation of arfolitixorin's potential to benefit patients with this devastating disease, said Ulf Jungnelius, chief executive officer, Isofol Medical, in the press release.

The use of arfolitixorin for the treatment of in patients with advanced CRC is being investigated in the phase 3 randomized, multicenter, parallel-group AGENT study (NCT03750786) of 490 patients. In the study, arfolitixorin alone is compared with leucovorin in combination with 5 fluorouracil, oxaliplatin, and bevacizumab (Avastin) to evaluate the primary end point of objective response rate. The study is also exploring progression-free survival and duration of response as secondary end points.2

Recruitment was recently completed for the study across approximately 90 centers located in the United States, Canada, Europe, Australia, and Japan.3 Those enrolled were males and females aged 18 years or older who had colorectal adenocarcinoma verified by biopsy, available tumor tissue for biopsy, evaluable disease with at least 1 measurable lesion, a life expectancy of over 4 months, an ECOG performance status of 0 or 1, and adequate laboratory test results at screening.2

“Our next clinical milestone is reaching 300 progression-free survival events in the phase III AGENT study which means that data can be deblinded so that we can analyze and present top-line results in the first half of 2022. The fast track designation will enable us to engage more frequently with the FDA to optimally plan for the continued development of arfolitixorin and potentially make it the first novel drug to improve the standard of care in mCRC in over 40 years,” said Jungnelius, in the press release.1

Upon conclusion of the study in 2022, the developer of arfolitixorin plans to apply for approval from the FDA and the European Medicines Agency.


1. Isofol Medical AB (publ) receives fda fast track designation for arfolitixorin in advanced colorectal cancer (mCRC). News release. Isofol Medical AB. November 23, 2021. Accessed November 24, 2021.

2. A study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5 fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancer (AGENT). Accessed November 24, 2021.

3. ISOFOL Completes recruitment of japanese patients in the global phase III AGENT study. News release. Isofol Medical AB. May 6, 2021. Accessed November 24, 2021.

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