Gallium Ga-68 gozetotide

Gallium (Ga) 68 prostate-specific membrane antigen (PSMA)-11, or Ga-68 gozetotide, is a radiopharmaceutical agent used to identify and assess prostate-specific membrane antigen (PSMA)-positive lesions in adult men with prostate cancer during positron emission tomography (PET).^L26981 Prostate cancer is one of the most commonly diagnosed cancers among men in Western countries and many patients treated with androgen-deprivation therapy relapse with castration-resistant prostate cancer.^A225396 In nearly all prostate cancers, malignant cells express a transmembrane protein called prostate-specific membrane antigen (PSMA).^A225396 Ga-68 PSMA-11 is an imaging agent that binds PSMA during positron emission tomography: it emits positrons to indicate the presence of PSMA-positive prostate cancer lesions in patients with suspected prostate cancer or in patients who may have recurrent prostate cancer.^L27006

On December 1, 2020, Ga-68 PSMA-11 was approved by the FDA as the first molecular-targeted drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.^L27006 It is administered intravenously. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended Ga-68 gozetotide be granted marketing authorization for the diagnosis of prostate cancer.^L43542 In December of the same year, the drug was fully authorized by the EMA.^L44682 In Octer 2022, Ga-68 PSMA-11 was approved by Health Canada for diagnostic use in men with prostate cancer.^L45598