This medicinal product is for diagnostic use only. Locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high risk PCa prior to primary curative therapy, Suspected PCa recurrence in patients with increasing levels of serum prostate specific antigen (PSA) after primary curative therapy, Identification of patients with PSMA positive progressive metastatic castration resistant prostate cancer (mCRPC) for whom PSMA targeted therapy is indicated (see section 4.4).
LOCAMETZ β NOVARTIS, approved 2025-03-28 (NDA215841).
306 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System β they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.