FDA Approves New PET Imaging Drug for Prostate Cancer

December 1, 2020 – The U.S. FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), developed by the University of California, as the first drug indicated for use in positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men who have prostate cancer. Ga 68 PSMA-11 is a radioactive diagnostic agent approved for use in patients who have suspected prostate cancer metastasis (cancer that has spread beyond the prostate) or who have suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels.

Prostate cancer is one of the most common forms of cancer in the United States. Imaging through methods such as ultrasound, CT scans, bone scans, MRI, and PET is necessary to assess a patient’s disease. It allows the patient’s healthcare team to investigate the status of the primary tumor, lymph nodes, and any bone metastasis.

In clinical studies, Ga 68 PSMA-11 was successful in providing clinically important information via PET diagnostics to inform treatment approaches for patients diagnosed with prostate cancer. The drug is administered via intravenous infusion prior to the patient’s PET scan by a healthcare professional. The drug binds to PSMA, a substance that prostate cancer cells usually have in high amounts on their surfaces. The PET scan then picks up on the positrons emitted by the drug, allowing diagnosticians to see the presence of PSMA-positive prostate cancer lesions in the body.

The use of Ga 68 PSMA-11 in PET imaging does carry a risk for misdiagnosis, as the substance may bind to other types of cancer cells as well as some non-malignant tissues. The substance also has radiation risks, as it contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer.

The drug has launched at an average wholesale price (AWP) of $5,400 per vial.