FDA Approves PET-Imaging Drug for Prostate Cancer


FDA approves Gallium 68 PSMA-11, the first drug for PET imaging of prostate-specific membrane antigen–positive lesions in patients with prostate cancer.

The FDA has approved Gallium 68 PSMA-11, the first drug for PET imaging of prostate-specific membrane antigen (PSMA)—positive lesions in patients with prostate cancer.

Specifically, the drug is indicated for patients with suspected prostate cancer metastasis who are potentially curable via surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for those with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen levels. The PET imaging drug is a radioactive diagnostic that is given via an intravenous injection.

“Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer,” said Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research, stated in a press release. “With this first approval of a PSMA-targeted PET imaging drug for men with prostate cancer, providers now have a new imaging approach to detect whether or not the cancer has spread to other parts of the body.”

Ga 68 PSMA-11 was developed to bind to PSMA, which is known to be a critical pharmacologic target for imaging in this disease, as cancer cells typically contain higher levels of this antigen. The radioactive agent releases positrons; as such, it can be imaged by PET to identify PSMA-positive lesions in tissue within the body, according to the regulatory agency.

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