The FDA has approved an abbreviated new drug application for a generic version of gallium Ga 68 gozetotide injection (Ga-68 PSMA-11), a PET imaging agent used to detect PSMA-positive lesions in prostate cancer. Developed by RadioMedix, this radioactive tracer supports more precise staging and detection of metastatic or recurrent disease.
The approval followed a successful FDA inspection of RadioMedix’s manufacturing facility, which received zero Form 483 observations, indicating no regulatory or quality system deficiencies.
Ga-68 PSMA-11 was originally approved in December 2020 as the first PSMA-targeted imaging agent for prostate cancer. Its approval was supported by two key Phase 3 trials: PSMA-PreRP, which showed about 90% specificity for detecting pelvic lymph node metastases in surgical candidates, and PSMA-BCR, which evaluated patients with biochemical recurrence and demonstrated detection rates up to 91% in those with higher PSA levels.
The agent has been generally well tolerated, with mild side effects such as nausea, diarrhea, and dizziness, alongside standard risks including radiation exposure and potential diagnostic inaccuracies.