FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer

FDA

1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography 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 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 FDA press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , US , Diagnostic agent