The FDA has approved Gallium 68 PSMA-11 for patients having prostate cancer imaging who are potentially treatable with surgery or radiation therapy.
The approval also covers patients with suspected prostate cancer recurrence, given their abnormal prostate-specific antigen (PSA) levels.
An intravenous radioactive diagnostic agent, the drug is the first compound supporting positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. More than 90% of prostate cancers results in higher than normal prostate-specific membrane antigen levels.
The radioactive drug belongs to a class of therapeutics known as radiotracers that collect in tumor cells, enhancing radioactive imaging techniques such as PET and computed tomography.
The drug is “an important tool that can aid health care providers in assessing prostate cancer,” explained Dr. Alex Gorovets, acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research in a statement.
FDA relied on two prospective clinical trials to make its decision involving 960 patients with prostate cancer.
A prior study published in 2018 concluded that Gallium 68 PSMA-11 provided “valuable diagnostic information and may inform the need for and extent of pelvic node dissection.”