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FDA gives nod to first PSMA-targeted PET tracer for prostate cancer

by John R. Fischer, Senior Reporter | December 03, 2020
Molecular Imaging
Gallium 68 PSMA-11 can be used to perform PET scans on patients with suspected prostate cancer metastasis or suspected prostate cancer recurrence
With FDA approval now secured, providers can perform Gallium 68 PSMA-11 PET scans on patients with suspected prostate cancer metastasis or suspected prostate cancer recurrence.

“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 Dr. Alex Gorovets, acting deputy director of the office of specialty medicine in FDA’s Center for Drug Evaluation and Research, in a statement.

The aim is to identify those who potentially could benefit from surgery or radiation therapy. The drug is administered as an intravenous injection that binds to the prostate-specific membrane antigen (PSMA), of which prostate cancer cells usually show high levels. It then emits positrons that the PET scan picks up on to show the presence of PSMA-positive cancer lesions in the tissues of the body.
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One clinical trial oversaw 325 patients with biopsy-proven prostate cancer undergo PET CT or PET/MR scans with Ga 68 PSMA-11. Each was considered for surgery to remove the prostate gland and pelvic lymph nodes, and was considered to be at higher risk for metastases. Those with positive readings in the pelvic lymph nodes had a clinically important rate of metastatic cancer confirmed by surgical pathology.

A second trial of 635 patients who showed signs of recurrent prostate cancer after undergoing prostate surgery or radiotherapy found 74% had at least one positive lesion detected in at least one body region, including bone, prostate bed, pelvic lymph node, or extra-pelvic soft tissue. Local recurrence or metastasis was confirmed in 91% of cases that had correlative tissue pathology from biopsies, baseline or conventional follow-up imaging results, and serial prostate-specific antigen levels.

Prostate cancer imaging is currently performed with F 18 fluciclovine and C 11 choline. Both, however, are only approved for use in patients with suspected cancer recurrence.

With the drug, providers expect to be able to spare patients from unnecessary surgeries and locate biochemical evidence of recurrent prostate cancer that can help them prescribe the best course of treatment. It also is expected to overcome the limitations of CT, MR and bone scans in identifying prostate cancer lesions.

FDA approval was granted to the University of California, Los Angeles and the University of California, San Francisco.

A dossier for a cold kit 68Ga-PSMA has been filed by the company Telix Pharma and is awaiting approval from FDA at a national level and from the EMA at an EU level under the brand name, illumet, according to MEDraysintell.

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