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Today, the US Food and Drug Administration has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11). It is the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) -positive lesions in men with prostate cancer.

Ga 68 PSMA-11 is used in patients with suspected prostate cancer metastasis (when cancer cells spread from where they were originally formed to another part of the body) and may be cured by surgery or radiation therapy. It will be applied. Ga 68 PSMA-11 is also indicated for patients with suspected recurrence of prostate cancer based on elevated serum prostate-specific antigen (PSA) levels. Ga 68 PSMA-11 is a radioactive diagnostic agent given in the form of an intravenous injection.

“Ga68PSMA-11 is an important tool to help healthcare providers assess prostate cancer,” said Alex Gorovets, MD, Deputy Director of the FDA’s Center for Drug Evaluation and Research. “With this initial approval of a PET imaging drug targeting PSMA for men with prostate cancer, providers now have a new imaging approach to detect whether the cancer has spread to other parts of the body. I will. “

Prostate cancer is the third most common form of cancer in the United States. According to the National Cancer Institute, it is estimated that there will be more than 190,000 new cases of prostate cancer and an estimated 33,000 deaths from the disease in 2020. Computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, and bone scans are traditional methods commonly used to image patients with prostate cancer, but these approaches are for prostate cancer. Limited to lesion detection. F18 flucyclobin and C11 choline are two other PET drugs approved for diagnostic imaging of prostate cancer. However, it is only approved for use in patients with suspected cancer recurrence.

When administered by injection, Ga 68 PSMA-11 binds to PSMA. This is an important pharmacological target for prostate cancer imaging, as prostate cancer cells usually contain high levels of antigens. As a positron-emitting radiopharmaceutical, Ga 68 PSMA-11 can be imaged with PET to indicate the presence of PSMA-positive prostate cancer lesions in body tissues.

The safety and efficacy of Ga 68 PSMA-11 was evaluated in two prospective clinical trials in a total of 960 men with prostate cancer who received each single injection of Ga 68 PSMA-11. In the first trial, 325 patients with biopsy-proven prostate cancer underwent PET / CT or PET / MRI scans with Ga 68 PSMA-11. These patients were candidates for surgical resection of the prostate and pelvic lymph nodes and were considered at high risk of metastasis. Surgical pathology confirmed the incidence of clinically significant metastatic cancer in patients who underwent surgery and who tested positive for the pelvic lymph nodes of Ga 68 PSMA-11 PET. The availability of this information before treatment is expected to have a significant impact on patient care. For example, you can prevent certain patients from undergoing unnecessary surgery.

The second trial enrolled 635 patients who had elevated serum PSA levels after the first prostate surgery or radiation therapy and therefore had biochemical evidence of recurrent prostate cancer. All of these patients underwent one Ga 68 PSMA-11 PET / CT scan or PET / MR scan. Based on scans, 74% of these patients had at least one positive lesion detected by Ga 68 PSMA-11PET in at least one body area (bone, prostate bed, pelvic lymph nodes, or extrapelvic soft tissue). I had it. Ga 68 PSMA-11 PET measurements with correlated histopathology from biopsy, results of baseline or follow-up imaging by conventional methods, and continuous PSA levels available for comparison and confirmed local recurrence or metastasis of prostate cancer An estimated 91% of cases with positive values. Therefore, in the second trial, Ga 68 PSMA-11 PET can detect the disease site of patients with biochemical evidence of recurrent prostate cancer, which is important and may influence the approach to treatment. It has been demonstrated that it can provide information.

There were no serious side effects due to Ga 68 PSMA-11. The most common side effects for Ga 68 PSMA-11 were nausea, diarrhea and dizziness. There is a risk of misdiagnosis because Ga 68 PSMA-11 binding can occur in other types of cancer or in certain non-malignant processes that can lead to image interpretation errors. Ga 68 PSMA-11 is at radiation risk because it contributes to the patient’s overall long-term cumulative radiation exposure associated with an increased risk of cancer.

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

The FDA, an agency within the U.S. Department of Health and Human Services, by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other human biological products, and medical devices. Protects public health. The agency is also responsible for the safety and security of our food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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