Gallium (68Ga) gozetotide
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| Clinical data | |
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| Other names | GALLIUM GA-68 GOZETOTIDE; (68)Ga Labeled Glu-NH-CO-NH-Lys(ahx)-hbed-CC |
| AHFS/Drugs.com | |
| Routes of administration | intravenous (IV)[1] |
| Pharmacokinetic data | |
| Excretion | Urine[1] |
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Gallium 68 PSMA-11 or Ga 68 PSMA-11 is a radiopharmaceutical made of 68Ga conjugated to prostate-specific membrane antigen (PSMA) targeting ligand, Glu-Urea-Lys(Ahx)-HBED-CC, used for imaging prostate cancer by positron emission tomography (PET).[2] The PSMA targeting ligand specifically directs the radiolabeled imaging agent towards the prostrate cancerous lesions in men. [3] This is the first drug approved by USFDA as a PET imaging agent.[3]
Developement
Initially Gallium (68Ga) chloride solution injections used for radiolabelling,[4] in 2019 European Pharmacopoeia mentions Gallium (68Ga) DOTATOC injection for radiolabelling and PET imaging.[5]
Ga 68 PSMA-11 is co-developed by University of California, Los Angeles and University of California, San Francisco, they conducted phase 3 clinical trial.[6] On 1st December 2020, the drug was first approved by USFDA for PET imaging.[3]
Usage
Ga 68 PSMA-11 Injections are used for PET imaging of prostate-specific membrane antigen (PSMA) positive lesions in males with prostate cancer. It can be given for the patients with suspected metastasis, and the candidates with initial definitive therapy.[1]
Mechanism of Action
PSMA-11, Glu-Urea-Lys(Ahx)-HBED-CC of Ga 68 PSMA-11, directs and binds with prostate-specific membrane antigen (PSMA). This usually binds to cells that overexpress PSMA, such as the malignant prostate cancer cells. The radioactive Isotope of Gallium, Ga-68 is responsible for emitting β+ radiations and X-rays. This helps in recording images by positron emission tomography (PET) and CT scan.[1]
References
- ^ a b c d "HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Gallium Ga 68 PSMA-11 Injection safely and effectively. See full prescribing information for Gallium Ga 68 PSMA-11 Injection" (PDF). accessdata.fda.gov. FDA.
- ^ "gallium Ga 68 gozetotide". www.cancer.gov. 2 February 2011.
- ^ a b c Commissioner, Office of the (2 December 2020). "FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer". FDA. Retrieved 9 November 2021.
This article incorporates text from this source, which is in the public domain.
- ^ European Pharmacopeia (2018): Gallium (68Ga) Chloride Solution for Radiolabelling. 2018. p. 1148.
- ^ European Pharmacopeia 10.0: Gallium (68Ga) DOTATOC injection. 2019. p. 1208.
- ^ Carlucci, G; Ippisch, R; Slavik, R; Mishoe, A; Blecha, J; Zhu, S (February 2021). "68Ga-PSMA-11 NDA Approval: A Novel and Successful Academic Partnership". Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine. 62 (2): 149–155. doi:10.2967/jnumed.120.260455. PMC 8679592. PMID 33443068.
