FDA okayed the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer.
FDA approved the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
The University of California, Los Angeles and the University of California, San Francisco garnered FDA’s okay for Gallium 68 PSMA-11 (Ga 68 PSMA-11), a radioactive diagnostic agent administered via intravenous injection.
“Ga 68 PSMA-11 is an important tool that can aid healthcare 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, in a 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.”
Ga 68 PSMA-11 is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. The imaging drug is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels.
While computed tomography (CT) scans, magnetic resonance imaging (MRI) scans and bone scans are conventional methods commonly used to image patients with prostate cancer, they are limited in detection of prostate cancer lesions, according to FDA.
F 18 fluciclovine and C 11 choline are two other PET drugs that are approved for prostate cancer imaging. “However, they are only approved for use in patients with suspected cancer recurrence,” FDA said.
The safety and efficacy of Ga 68 PSMA-11 were evaluated in 2 prospective clinical trials with a total of 960 men with prostate cancer who each received one injection of Ga 68 PSMA-11.
No serious adverse reactions were attributed to Ga 68 PSMA-11. However, there is a risk for misdiagnosis, FDA said, because Ga 68 PSMA-11 binding may occur in other types of cancer as well as certain non-malignant processes which may lead to image interpretation errors.