Siemens’ PETNET Solutions, a wholly owned subsidiary of Siemens Healthcare, has received Abbreviated New Drug Application (ANDA) approval from FDA to manufacture and distribute the PET radiopharmaceutical sodium fluoride F 18 injection (18F NaF) across its entire national network of radiopharmacies. The approval provides coverage to 99 percent of the US population.
18F NaF is indicated for positron emission tomography bone imaging to define areas of altered osteogenic activity in the body, including metastatic bone disease from cancer. Multiple clinical studies have demonstrated improved sensitivity and specificity of PET/computed tomography (PET/CT) imaging compared to single-photon emission computed tomography (SPECT)/planar bone imaging.1-4 Early identification of patients at higher risk for developing bone metastases enables practitioners to be proactive in their diagnosis and treatment.5
With ANDA approval of 18F NaF throughout its national network of radiopharmacies, Siemens’ PETNET Solutions continues its longstanding support of 18F NaF PET in the molecular imaging community as well as its efforts to improve patient access. In 2009, Siemens’ PETNET Solutions supplied the American College of Radiology Imaging Network (ACRIN) with 18F NaF for its multi-center clinical trials. During the 2010 global molybdenum shortage that impacted access to SPECT bone scans, Siemens’ PETNET Solutions offered 18F NaF free of charge for a limited time to hospitals and imaging centers, helping to ensure patient access to metastatic bone disease evaluation via PET/CT bone scans.
1. Even-Sapir, E., Metser, U., Mishani, E., Lievshitz, G., et al. (2006). The Detection of Bone Metastases in Patients with High-Risk Prostate Cancer: 99mTc-MDP Planar Bone Scintigraphy, Single- and Multi-Field-of-Vew SPECT, 18F-Fluoride PET, and 18F-Fluoride PET/CT. J Nucl Med, 47(2), 287-97.
2. Gerety, E.L., Lawrence, E.M., Wason, J., Yan, H., et.al. (2015). Prospective Study Evaluating the Relative Sensitivity of 18F-NaF PET/CT for Detecting Skeletal Metastases from Renal Cell Carcinoma in Comparison to Multidetector CT and 99m TC-MDP Bone Scintigraphy, Using an Adaptive Trial Design. Ann Oncol, Jul 22. pii: mdv289
3. Schirrmeister, H., Guhlmann, A., Kotzerke, J., Santjohanser, C., et al. (1999). Early Detection and Accurate Description of Extent of Metastatic Bone Disease in Breast Cancer with Fluoride Ion and Positron Emission Tomography. J Clin Oncol, 17(8), 2381-9.
4. Schirrmeister, H., Glatting, G., Hetzel, J., Nüssle, K., et al. (2001). Prospective Evaluation of the Clinical Value of Planar Bone Scans, SPECT, and 18F-Labeled NaF PET in Newly Diagnosed Lung Cancer. J Nucl Med, 42(12), 1800-4.
5. Blum, R. H, Shasha, D., & Fleishman, S.B. (2003). The Multidisciplinary Approach to Bone Metastases. Cancer Network. Available at: http://www.cancernetwork.com/bone-metastases/multidisciplinary-approach-bone-metastases