A radiopharmaceutical for diagnosing prostate cancer, developed using domestic technology, has received regulatory approval, adding its name to the list of Korea-developed new drugs.
The Ministry of Food and Drug Safety (MFDS) said Tuesday that it approved "Prostaview Injection (Florastamine (18F))," a radiopharmaceutical used to diagnose prostate cancer lesions, on December 30. With this approval, the product has been designated as the 43rd new drug developed in Korea.
Prostaview Injection is a radiopharmaceutical that selectively binds to prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells. This helps identify cancer lesions more precisely in imaging tests.
During the approval process, the MFDS formed a dedicated product team and conducted priority reviews for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards. The ministry also supported the review process through customized face-to-face meetings with the developer.
"This will enable more accurate identification of lesions in patients with recurrent or metastatic prostate cancer who have shown abnormal findings in existing imaging tests," an MFDS official said. "We expect it to help set treatment directions tailored to each patient."
