FDA grants fast track designation to arfolitixorin for metastatic colorectal cancer
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The FDA granted fast track designation to arfolitixorin for treatment of patients with metastatic colorectal cancer.
Arfolitixorin (Isofol Medical AB) is a stabilized and biologically active pure form of folate ([6R]-5,10-methylenetetrahydrofolic acid).
The randomized phase 3 AGENT study is underway to assess the agent, designed to increase the efficacy of standard chemotherapy. Researchers will assign 440 patients to 5-FU, oxaliplatin and bevacizumab (Avastin, Genentech) plus either arfolitixorin or leucovorin as first-line treatment for metastatic colorectal cancer.
The primary endpoint is overall response rate. Secondary endpoints include PFS, duration of response, OS, number of curative metastasis resections, safety and patient-reported outcomes.
Topline data are expected to be available in the first half of 2022.
“We are thrilled that the FDA has granted fast track designation to our lead candidate, arfolitixorin,” Ulf Jungnelius, CEO of Isofol, said in a company-issued press release. “This serves as a strong external validation of arfolitixorin’s potential to benefit patients with this devastating disease. ... 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 [metastatic colorectal cancer] in over 40 years.”
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