FDA approves first PSMA-targeted radiotracer
medwireNews: The US FDA has permitted the use of 68gallium-labeled prostate-specific membrane antigen (68Ga-PSMA-11) as a tracer for positron emission tomography (PET) to detect prostate cancer metastases or recurrence.
The radiotracer, which is administered intravenously, is indicated for potentially curable patients with suspected metastasis and also for those with suspected recurrence on the basis of increased prostate-specific antigen (PSA) concentrations.
The decision is based on data from two clinical trials, the first of which comprised 325 participants and showed that positive readings on 68Ga-PSMA-11 PET were associated with “a clinically important rate of metastatic cancer confirmed by surgical pathology.” The second study – which included 635 patients with rising PSA levels after initial surgery or radiotherapy – demonstrated the utility of 68Ga-PSMA-11 PET to detect recurrent disease.
“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,” said Alex Gorovets, from the FDA’s Center for Drug Evaluation and Research, in a press release.
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