What is SomaKit TOC - Edotreotide and what is it used for?
SomaKit TOC is a diagnostic medicine used in adult patients who are believed to present well-differentiated forms of neuroendocrine tumors of the gastroenteropancreatic tract (GEP-NET). GEP-NETs are tumors that start in types of cells in the intestine or pancreas that normally release hormones. Later tumors can spread to other parts of the body (metastasis).
SomaKit TOC is used with a technique called positron emission tomography (PET) in order to acquire images that localize tumors. SomaKit TOC contains the active ingredient edotreotide. The medicine is not used directly, but must be "radiolabelled" before being injected, which means that it is marked 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 March 19, 2015
How is SomaKit TOC - Edotreotide used?
SomaKit TOC is available as a kit for preparing an injectable solution. It is given as a single injection into a vein immediately after being radiolabelled. PET scan images are then acquired 40-90 minutes later.
SomaKit TOC can only be obtained with a prescription. The injection should be prepared and administered only by personnel experienced in the use of radioactive medicinal products in a suitable structure.
For more information, see the package leaflet.
How does SomaKit TOC - Edotreotide work?
The active ingredient of SomaKit TOC, edotreotide, specifically binds to receptors called somatostatin receptors on the cell surface. Not all cells have these receptors, but most of those of well-differentiated GEP-NETs have high amounts on the surface. The prepared medicine, radiolabelled with gallium (68Ga) chloride, binds to these receptors on GEP-NET cells. The consequent radiation accumulation can be detected by the special PET machinery. This allows to detect where the tumors are located and their possible spread.
What benefit has SomaKit TOC - Edotreotide shown during the studies?
The active ingredient of SomaKit TOC, gallium-bound edotreotide (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 (as the scans well identified patients with GEP-NET or their metastases), others analyzed their specificity (how reliable were the scans in identifying subjects without GEP-NET) and some referred to the rate of injury detection (how much scans could identify tumors). A comparison was also presented using data from many 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 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 which showed that the former had better sensitivity. The results of further studies indicated that gallium-labeled edotreotide (68Ga) chloride had a sensitivity and specificity of 100% and 89% respectively and a 75% injury detection rate. In four other comparative studies it was observed that the active ingredient of SomaKit TOC detected more tumors than did indium (111In) pentetreotide 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 medicinal product has been demonstrated. The risks of side effects seem to be low; the CHMP therefore decided that SomaKit TOC's benefits are greater than its 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?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of SomaKit TOC have been included in the summary of product characteristics and the package leaflet.
More information on SomaKit TOC - Edotreotide
For the full EPAR version of SomaKit TOC, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with SomaKit TOC, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The summary of the opinion of the Committee for Orphan Medicinal Products related to SomaKit TOC is available on the Agency's website: ema.europa.eu/Find medicine / Human medicines / Rare disease designation.
