FDA Approves PET Imaging Prostate Cancer Drug

FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), the first drug for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer. The approval was granted to UCLA and the University of California, San Francisco.

An agency statement says Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. It also is indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen levels.

Ga 68 PMSA-11 is described as a radioactive diagnostic agent that is administered in the form of an intravenous injection.

The drug’s safety and efficacy were evaluated in two prospective clinical trials with a total of 960 men with prostate cancer. No serious adverse reactions were attributed to Ga 68 PSMA-11, the agency says. The most common adverse reactions were nausea, diarrhea, and dizziness.