FDA Approves First PSMA-targeted PET Imaging Agent for Prostate Cancer

FDA Approves First PSMA-targeted PET Imaging Agent for Prostate Cancer
The U.S. Food and Drug Administration (FDA) has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) as a positron emission tomography or PET imaging agent for men with prostate cancer. The molecule is the first approved PET imaging agent that detects prostate cancer lesions by targeting the prostate-specific membrane antigen (PSMA) — a protein produced at high levels by prostate cancer cells. It is approved for patients suspected of cancer recurrence, based on elevated blood levels of prostate-specific antigen (PSA), a prostate cancer biomarker. The agent also can be used for those with suspected prostate cancer metastasis — when the cancer spreads to distant regions in the body — who might be cured by surgery or radiation therapy. Other PET agents have been approved for detecting recurrent prostate cancer, but none for men whose cancer is suspected of spreading. “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,” Alex Gorovets, MD, acting deputy director of the office of specialty medicine in the FDA’s Center for Drug Evaluation and Research, said in a press release. Ga 68 PSMA-11, developed by researchers at the University of California, Los Angeles and the University of California, San Francisco, is a radioactive agent meant to be given as an intravenous (into-the-bloodstream) injection prior to PET scanning. Once inside the body, it binds and accumulates inside prostate cancer lesions containing the PSMA protein, allowing clinicians to visualize these lesions in PET scans. The decision to approve Ga 68 PSMA-11 was based, according to the researchers, on the results from two clinical stu
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