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New Drugs Approved In December

Ga 68 PSMA-11
Ga 68 PSMA-11

On December 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Developed by the University of California, Los Angeles and the University of California, San Francisco, Ga 68 PSMA-11, a radioactive diagnostic agent, is indicated for patients with suspected prostate cancer metastasis who are potentially curable by surgery or radiation therapy. It is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels.

Ga 68 PSMA-11 binds to PSMA, an important pharmacologic target for prostate cancer imaging because prostate cancer cells usually contain elevated levels of the antigen.

A risk for misdiagnosis is involved with Ga 68 PSMA-11 as binding may occur in other types of cancer as well as certain non-malignant processes which may lead to image interpretation errors.

According to the National Cancer Institute, prostate cancer is the third most common form of cancer in the United States.

The drug is under review with European Medicines Agency.