FDA Approves First PET Imaging Drug for Prostate-Specific Membrane Antigen Positive Lesions in Prostate Cancer

The radioactive diagnostic agent, Gallium 68 PSMA-11, can detect suspected prostate cancer metastasis or recurrence, providing another imaging option for these patients.

The Food and Drug Administration (FDA) approved the first radioactive diagnostic agent, Gallium 68 PSMA-11, for positron emission tomography (PET) imaging in men with prostate cancer who have prostate-specific membrane antigen positive lesions.

This drug, delivered intravenously, has been indicated for patients with suspected prostate cancer metastasis, or when cancer spreads from its original location to another part within the body that can potentially be cured by radiation therapy or surgery, according to a press release from the FDA. It is also indicated for patients with suspected prostate cancer recurrence via elevated serum prostate-specific antigen levels, an indicator for prostate cancer measured within blood.

“(Gallium) 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer,” said Dr. Alex Gorovets, acting deputy director of the Office of Specialty Medicine at the FDA’s Center for Drug Evaluation and Research, in the press release. “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.”

Before this approval, only two PET drugs have previously been approved for the imaging of prostate cancer, but only in patients with suspected cancer recurrence. Approving Gallium 68 PSMA-11 allows for another imaging tool to detect if patients have prostate cancer, the third most common form of cancer in the U.S.

The effectiveness and safety of this imaging drug were assessed in two clinical trials, both of which were successful. Some implications for patient care include sparing patients from unnecessary surgery and providing helpful information to determine the appropriate therapy approach, according to the release.

Although no serious adverse reactions were linked to Gallium 68 PSMA-11, some common adverse reactions may occur such as diarrhea, nausea and dizziness. Image interpretation errors may also occur due to a similar binding occurring in other types of cancers and nonmalignant processes. The risk for radiation is also present, which in turn can also increase a patient’s risk for cancer.

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