FutureChem's FC-705 receives orphan drug designation for prostate cancer treatment

FutureChem, a Korean radiopharmaceutical company, said on Tuesday that FC-705, the company's prostate cancer treatment, has received orphan drug designation from the Ministry of Food and Drug Safety (MFDS).

This designation aligns with MFDS’s Regulations on Designation of Orphan Drugs, which consider criteria such as the size of the patient population, restricting the designation to pharmaceuticals intended for diseases affecting 20,000 patients or fewer in the Korean population. The designation also aims to meet the need for effective treatments in areas lacking suitable therapies or where existing pharmaceuticals require significant improvements in terms of safety or efficacy.

As a result of this designation, FC-705 will benefit from the government support and fee reductions for its approval process. Moreover, it is anticipated to undergo a streamlined pathway to market, including exemptions from certain safety and efficacy data reviews and expedited approval reviews by the MFDS.

FC-705, now designated as an orphan drug in development, is a radiopharmaceutical that combines a peptide of prostate-specific membrane antigen (PSMA)—an enzyme found “exclusively in prostate cancer cells”—with the beta particle-emitting radioisotope Lu-177, as described by FutureChem. The treatment delivers beta radiation released from Lu-177 to prostate cancer cells through blood vessels.  

FutureChem also said that initial phase 1 trials demonstrated “superior therapeutic efficacy at half the dose of competitors.” Currently, FC-705 is advancing through phase 2 clinical trials in Korea and phase 2a trials in the United States.

For patients with metastatic castration-resistant prostate cancer (mCRPC) who have exhausted standard therapies, FC-705 presents a potential new option in the evolving landscape of radioligand therapy.

A spokesperson from FutureChem underscored the significance of FC-705 receiving orphan drug designation at this stage of development, stating, “Despite existing alternatives, FC-705 has demonstrated superior clinical outcomes based on both preclinical and clinical data.”

Meanwhile, phase 2 clinical trials in Korea have seen significant progress: 90 percent of patients have completed repeat dosing, and total patient dosing is expected to conclude by October this year.