The Food and Drug Administration (FDA) has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), 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, a radioactive diagnostic agent, is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. It is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels. 

The approval was based on efficacy and safety data from 2 prospective clinical trials (Trial 1 and 2) with a total of 960 men with prostate cancer who each received 1 injection of Ga 68 PSMA-11. Trial 1 included 325 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans performed with Ga 68 PSMA-11. Results from the study showed that positive readings in the pelvic lymph nodes on Ga 68 PSMA-11 PET were associated with a clinically important rate of metastatic cancer confirmed by surgical pathology in those who proceeded to surgery. 

In Trial 2, 635 patients with rising serum PSA levels after prostate surgery or radiotherapy received a single Ga 68 PSMA-11 PET/CT scan or PET/MR scan. Findings demonstrated that 74% of patients had at least 1 positive lesion detected by Ga 68 PSMA-11 PET, and local recurrence or metastasis of prostate cancer was confirmed in 91% of cases.


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“Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer,” said Alex Gorovets, MD, 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.”

As for safety, there were no serious adverse events reported with Ga 68 PSMA-11. The most common adverse reactions included nausea, diarrhea and dizziness. In addition to radiation risks, there is a risk for misdiagnosis with Ga 68 PSMA-11 as it may bind to other types of cancer or certain non-malignant processes, potentially leading to interpretation errors.

For more information visit fda.gov.

Reference

FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. [press release]. Silver Spring, MD: US Food and Drug Administration; December 1, 2020.