FDA Approves Targeted PET Imaging Agent for Men with Prostate Cancer

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

The FDA granted the approval to the University of California, Los Angeles and the University of California, San Francisco.

Gallium 68 PSMA-11 is indicated for patients with suspected prostate cancer that has spread from the place where it first formed to another part of the body. The agent is also indicated for patients with suspected prostate cancer recurrence that is based on elevated levels of serum prostate-specific antigen.

Prostate cancer is the third most common form of cancer in the U.S. It is estimated that there will be more than 190,000 new cases of prostate cancer and an estimated 33,000 deaths from the disease in 2020.