FDA approves imaging agent to detect prostate cancer

Hannah Blake

pharmaphorum

The Mayo Clinic’s Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer, has been approved for production and use by the US FDA.

Choline C 11 Injection is administered intravenously to produce an image, which helps to locate specific body sites for follow-up testing. It is performed in patients whose blood prostate specific antigen (PSA) levels are increasing after earlier treatment for prostate cancer. An elevated PSA result suggests that prostate cancer may have returned, even though conventional imaging tests have not produced a result.

“Choline C 11 Injection provides an important imaging method to help detect the location of prostate cancer in patients whose blood tests suggest recurrent cancer when other imaging tests are negative. The FDA’s approval of Choline C 11 Injection at the Mayo Clinic provides assurance to patients and health care professionals they are using a product that is safe, effective, and produced according to current good manufacturing practices.”

Charles Ganley, M.D., director of the Office of Drug Evaluation IV in FDA’s Center for Drug Evaluation and Research.

Four independent studies examined the safety and effectiveness of Choline C 11 Injection, which tested a total of 98 patients with elevated blood PSA levels but no sign of recurrent prostate cancer on conventional imaging. In each of the studies, at least half the patients who had abnormalities detected on PET scans also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas.

EU-Clinical-Trial-Directive-Regulatory-Requirements-20Sep12

Reference links:

FDA

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