FDA Grants Fast Track Designation to Arfolitixorin for Treatment of Advanced Colorectal Cancer


Arfolitixorin was granted a fast track designation by the FDA for advanced colorectal cancer based on its potential to address unmet medical needs.

The FDA has granted fast track designation to arfolitixorin (6R-MTHF) for patients with metastatic colorectal cancer (CRC), according to a press release from developer Isofol Medical AB.

Arfolitixorin is a stabilized and biologically active pure form of the folate that helps to increase 5-fluorouracil (5-FU)–cytotoxicity. The decision from the FDA comes with the potential for arfolitixorin to fulfill currently unmet clinical needs and to offer more effective treatment options for patients with metastatic disease. Arfolitixorin is currently under evaluation as part of the phase 3 AGENT study (NCT03750786), which seeks to assess progression-free survival events among patients treated with the drug.

“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,” Ulf Jungnelius, chief executive officer at Isofol, said in a press release.

The clinical trial enrolled 490 patients with advanced CRC who were randomized to receive either arfolitixorin or a leucovorin plus 5-FU combination. The primary end point of the study is to assess the overall response rate, with key secondary end points including progression-free survival and duration of response. In group A, patients will receive arfolitixorin and 5-FU, oxaliplatin, and bevacizumab and those in group B, patients will receive leucovorin, 5-FU, oxaliplatin, and bevacizumab (Avastin).

In order to be eligible for the trial, patients were required to have colorectal adenocarcinoma that was verified via a biopsy, as well as having availability of biopsy material. Additionally, patients were required to have non-resectable metastatic disease with plans to receive a first-line therapy consisting of 5-FU, oxaliplatin, and bevacizumab. It was also necessary for patients to have evaluable disease with at least 1 measurable lesion.

Isofol hopes to conclude the phase 3 study by the end of 2022 and apply for approval for arfolitixorin with the FDA and European Medicines Agency.


Isofol Medical AB (publ) receive FDA fast track designation for arfolitixorin in advanced colorectal cancer. News Release. Isofol Medical AB. November 23, 2021. Accessed December 2, 2021. https://yhoo.it/3rvkSnd

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