Locametz FDA Approval History
Last updated by Judith Stewart, BPharm on April 5, 2022.
FDA Approved: Yes (First approved March 23, 2022)
Brand name: Locametz
Generic name: gallium Ga 68 gozetotide
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Positron Emission Tomography Imaging
Locametz (kit for the preparation of gallium Ga 68 gozetotide injection) after radiolabeling with gallium-68, is a radioactive diagnostic agent used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer.
- Locametz is indicated for PET of PSMA-positive lesions in men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
- for selection of patients with metastatic prostate cancer, for whom Pluvicto (lutetium Lu 177 vipivotide tetraxetan) PSMA-directed therapy is indicated. Gallium-68 labeled Locametz can identify tumor lesions expressing the PSMA biomarker and locate where in the body tumors may have spread.
- Locametz is administered as slow intravenous injection. PET whole body images are acquired 50 minutes to 100 minutes after administration.
- Locametz contributes to a patient’s overall long-term cumulative radiation exposure. Safe handling and preparation procedures must be followed to protect patients and health care workers from unintentional radiation exposure.
- Common adverse reactions include fatigue, nausea, constipation, and vomiting.
Development timeline for Locametz
|Mar 23, 2022
|Approval FDA Approves Locametz (kit for the preparation of gallium Ga 68 gozetotide injection) for PSMA PET Imaging in Patients with Prostate Cancer
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