FutureChem said Monday that the Ministry of Food and Drug Safety (MFDS) has approved Prostavue Injection (florastamin F-18), its radiopharmaceutical diagnostic agent for prostate cancer, as Korea’s 43rd novel drug.
FutureChem’s Prostavue Injection, a PSMA-targeted PET diagnostic radiopharmaceutical for prostate cancer, won MFDS approval as Korea’s 43rd novel drug. (Credit: FutureChem)
With the approval, FutureChem has expanded its diagnostic radiopharmaceutical portfolio to four products, following its FLT lung cancer diagnostic agent, PDView Injection for Parkinson’s disease and Alzavue Injection for Alzheimer’s disease.
Prostavue is a PET diagnostic agent that combines the positron-emitting radioisotope fluorine-18 with a peptide targeting prostate-specific membrane antigen (PSMA), a protein highly expressed in prostate cancer. After intravenous administration, the agent binds to cancer cells, allowing PET-CT scans to identify the location and condition of tumors more precisely.
The approval was based on a phase 3 trial conducted at 11 institutions in Korea, which confirmed the product’s safety and efficacy, the company said.
In the trial, conducted in prostate cancer patients suspected of recurrence or metastasis, Prostavue met its primary efficacy endpoint, showing a positive predictive value (PPV) of 86.96 percent. The lower limit of the 95 percent confidence interval was 79.01 percent, exceeding the predefined threshold of 60.6 percent.
By comparison, conventional imaging tests in the same clinical setting, including CT, MRI, and bone scans, showed a PPV of about 60.16 percent. Prostavue demonstrated a 26.79 percentage point improvement, supporting its clinical value as a PSMA-PET-based diagnostic radiopharmaceutical with higher diagnostic accuracy and a lower false-positive rate than existing imaging methods.
FutureChem said it plans to accelerate supply in Korea and expand overseas, including in China, following the approval.
“We have completed product optimization through collaboration with Trasis, a Belgium-based company specializing in automated radiopharmaceutical synthesis systems, laying the groundwork for global market entry,” the company said. “The prostate cancer PET-CT diagnostic market has grown into a major segment, with more than 400,000 annual uses in the U.S., and we expect Korea’s market to expand rapidly as well.”
Prostate cancer is the most commonly diagnosed cancer among men in Korea. The related diagnostic market is projected to grow to about $13.16 billion by 2030, according to Grand View Research, raising expectations that Prostavue could become one of FutureChem’s key revenue drivers.
Lee Han-soo
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