Florastamin F-18

FutureChem, a Seoul radiopharmaceutical company, developed florastamin (FC303) as a fluorine-18 PSMA ligand for PET imaging of prostate cancer. Korea's Ministry of Food and Drug Safety approved it on 30 April 2026 as ProstaView injection, the country's 43rd domestically developed new drug and its first home-grown prostate cancer diagnostic; first commercial sales followed on 20 August 2026, the four-month gap being the reimbursement notice and hospital code registration every new Korean drug waits through. The company romanises the brand as both ProstaView and Prostaview and the ingredient appears as florastamin, florastamine and, in one wire report, flortastamine.

The registrational evidence is a domestic phase 3 trial at 11 institutions in men whose conventional imaging suggested recurrence or metastasis. Positive predictive value, the primary endpoint, was 86.96 per cent with a 95 per cent confidence interval lower bound of 79.01, against a pre-specified benchmark of 60.6; the CT, MRI and bone scans those same patients had already had returned about 60.16 per cent. A separate prospective study in 59 men with suspected intermediate-risk disease (Clinical Nuclear Medicine, 2025) put sensitivity at 72.4 per cent and specificity at 83.3 per cent against biopsy, with multiparametric MRI more sensitive at 89.7 per cent but less specific at 66.7 per cent and the same overall accuracy of 78 per cent — a fair description of what PSMA PET adds to MRI rather than replaces.

Registered phase 3 trials also cover initial staging of high-risk prostate cancer, the setting where gallium-68 PSMA-11 and piflufolastat are already approved in the United States and Europe. The approval matters beyond Korea because it is the diagnostic half of a domestic theranostic pair: FutureChem's lutetium-177 therapy FC705 (ludotadipep) targets the same antigen and is in phase 3 in Korea, so the approved tracer is the selection tool that therapy will be filed with.