FDA Approves PSMA-Targeted PET Imaging Drug for Prostate Cancer

On December 1, 2020, the U.S. Food and Drug Administration (FDA) approved Gallium 68 PSMA-11 (Ga 68 PSMA-11)—the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. Ga 68 PSMA-11 is a radioactive diagnostic agent that is administered in the form of an intravenous injection.

Read the FDA announcement.

Posted 12/1/2020