What is SomaKit TOC - Edotreotide and what is it used for?
SomaKit TOC is a diagnostic medicine used in adult patients believed to have well-differentiated forms of neuroendocrine tumors of the gastroenteropancreatic tract (GEP-NET). GEP-NETs are tumors that start in types of cells in the gut or pancreas that normally release hormones. Thereafter, the tumors can spread to other parts of the body (metastasize).
SomaKit TOC is used with a technique called positron emission tomography (PET) in order to acquire images that locate tumors. SomaKit TOC contains the active ingredient edotreotide. The medicine is not used directly, but must be 'radiolabelled' before being injected, which means it is tagged with a separate substance that emits low amounts of radiation. The substance that is used for the radiolabelling of SomaKit TOC is called gallium (68Ga) chloride.
Because the number of patients with GEP-NET is low, the disease is considered 'rare' and SomaKit TOC was designated an 'orphan medicine' (a medicine used in rare diseases) on 19 March 2015
How is SomaKit TOC - Edotreotide used?
SomaKit TOC is available as a kit for preparing a solution for injection. It is given as a single injection into a vein immediately after being radiolabelled. The PET scan images are then acquired 40-90 minutes later.
SomaKit TOC can only be obtained with a prescription. The injection should only be prepared and administered by personnel experienced in the use of radioactive medicinal products in a suitable facility.
For more information, see the package leaflet.
How does SomaKit TOC - Edotreotide work?
The active substance in SomaKit TOC, edotreotide, binds specifically to receptors called somatostatin receptors on the cell surface.Not all cells have these receptors, but most of the well-differentiated GEP-NET cells have large amounts of them on the surface. The prepared medicinal product, radiolabelled with gallium (68Ga) chloride, binds to these receptors on the GEP-NET cells. The resulting accumulation of radiation can be detected by the special PET machinery. This allows us to detect where the tumors are located and their possible spread.
What benefit has SomaKit TOC - Edotreotide shown during the studies?
The active ingredient in SomaKit TOC, radiolabelled edotreotide with gallium (68Ga) chloride, has a well established use in the detection of GEP-NET. Therefore, the company provided information from many, mostly small, studies in the published literature to show the effectiveness of SomaKit TOC in detection activity. The studies included data on 970 patients. Some studies focused on the sensitivity of PET scans (how well the scans identified patients with GEP-NET or their metastases), others analyzed their specificity (how reliable the scans were in identifying subjects without GEP-NET) and some addressed the lesion detection rate (how far scans were able to identify tumors.) A comparison was also presented using data from several of these studies (a meta-analysis).
Taken together, the studies were sufficient to demonstrate the efficacy of SomaKit TOC in detection, despite the heterogeneity of the exact results. Regarding the localization of the primary GEP-NET, a study showed that the medicine had a sensitivity of 45% compared to 10% in patients treated with another approved diagnostic medicine, indium (111In) pentetreotide, and this was confirmed by another study showing that the former had better sensitivity. The results of further studies indicated that gallium (68Ga) chloride-labeled edotreotide had a sensitivity and specificity of 100% and 89%, respectively, and a lesion detection rate of 75%. In four other comparative studies it was observed that the active ingredient in SomaKit TOC detected more tumors than indium (111In) pentetreotide did in the same patients.
What are the risks associated with SomaKit TOC - Edotreotide?
After radiolabelling SomaKit TOC emits small amounts of radiation related to a low risk of cancer or hereditary abnormalities.
For the full list of restrictions or side effects reported with SomaKit TOC, see the package leaflet.
Why has SomaKit TOC - Edotreotide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the technical and diagnostic performance of the medicine has been demonstrated. The risks of side effects appear to be low; the CHMP therefore decided that the benefits of SomaKit TOC are greater. risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of SomaKit TOC - Edotreotide?
The recommendations and precautions that healthcare professionals and patients need to observe in order for SomaKit TOC to be used safely and effectively have been set out in the summary of product characteristics and package leaflet.
More information about SomaKit TOC - Edotreotide
For the complete version of the SomaKit TOC EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on SomaKit TOC therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The summary of the opinion of the Committee for Orphan Medicinal Products for SomaKit TOC is available on the Agency's website: ema.europa.eu/Find medicine / Human medicines / Rare disease designation.
The information on SomaKit TOC - Edotreotide published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
