The U.S. Food and Drug Administration (FDA) approved the first drug to be used for positron emissions tomography (PET) imaging for prostate cancer on Dec. 1.
That drug, Gallium 68 PSMA-11 (Ga 68 PSMA-11), is a radioactive agent administered by intravenous injection for diagnostic purposes. Ga 68 PSMA-11 is approved for use in patients whose doctors believe that prostate cancer has spread and who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 could also be used by patients whose serum prostate-specific antigen levels are elevated and whose doctors believe prostate cancer has returned.
“Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer,” said Alex Gorovets, M.D., acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research. “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.”
The National Cancer Institute (NCI) said that prostate cancer is the third most common form of cancer in the United States. The NCI estimates that more than 190,000 new diagnoses of prostate cancer will occur and that an estimated 33,000 will die from prostate cancer in 2020.
The conventional methods often used for imaging in patients who have prostate cancer – computed tomography (CT), bone scans and magnetic resonance imaging (MRI) scans – are limited in how well they detect prostate cancer lesions. There are two other PET drugs approved for prostate cancer imaging in patients whose cancer may have returned. Those are F 18 fluciclovine and C 11 choline.
There were two prospective clinical trials to evaluate the safety and effectiveness of GA 68 PSMA-11. The first trial involved 325 patients with biopsy-proven prostate cancer, and these were considered at higher risk of metastasis, although they were candidates for surgical removal of the prostate gland and pelvic lymph nodes. In the second trial, 635 patients with rising serum PSA levels after initial prostate surgery or radiotherapy received a single Ga 68 PSMA-11 PET/CT scan or PET/MR scan. More than 70% (74% according to the FDA), had at least one positive lesion detected by Ga 68 PSMA-11 PET in at least one body region (bone, prostate bed, pelvic lymph node or extra-pelvic soft tissue).
There were no serious adverse reactions attributed to GA 68 PSMA-11, although nausea, diarrhea and dizziness were reported.
The FDA granted approval to the University of California, Los Angeles and the University of California, San Francisco.
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