Prostaspect Injection Receives MFDS New Drug Approval
MFDS has approved Prostaspect Injection ([18F]Florastamine) for PET imaging in patients with recurrent or metastatic prostate cancer confirmed by abnormal conventional imaging (approval date: 2026-04-30). Excludes cases with only rising PSA.
Expected effects: confirmatory imaging, early staging and detection of micrometastases, restaging to guide treatment strategy, and reduction of unnecessary treatment due to high positive predictive value.
Future plans: finalize insurance coverage and pricing strategy with HIRA, expand post-market surveillance (PMS) and clinical research, and prepare for additional indications.
KOSDAQ Filing Information
Filing: Key Management Matters Related to Investment Decision (ProstaView Injection ([18F]Florastamin) New Drug Approval from Ministry of Food and Drug Safety)