What is Lymphoseek - tilmanocept used for?
Lymphoseek is a diagnostic medicine used in cancer patients to detect sentinel lymph nodes. The sentinel lymph nodes are the regional lymph nodes, which is the first site where the tumor is likely to spread. Once located, the sentinel lymph nodes are surgically removed and examined to assess the presence of tumor cells. This exam serves to guide the surgeon towards the possible removal of other lymph nodes during the same operation. On the contrary, if the presence of the tumor is not detected in the sentinel lymph nodes, a more invasive operation can be avoided. Lymphoseek is used in patients with breast cancer, melanoma (a skin cancer) or a type of oral cavity tumor known as localized squamous cell carcinoma. The medicine contains the active substance tilmanocept .
How is Lymphoseek - tilmanocept used?
Lymphoseek is a solution that is administered in the tissue or around the tumor tissue and which should bind and accumulate in nearby lymph nodes. Before being administered to the patient, Lymphoseek is "radiolabelled", ie "labeled" with a small amount of radiation. The lymph nodes, and therefore the possible site of tumor spread, are then localized with a special camera capable of detecting radiation
Lymphoseek should only be administered by qualified healthcare professionals who are experts in mapping lymph nodes. The medicine can only be obtained with a prescription.
How does Lymphoseek - tilmanocept work?
The active ingredient present in Lymphoseek, tilmanocept, binds to proteins called mannose binding proteins, which are present in high amounts in some immune cells in the lymph nodes. Because it is bound to these proteins, the radiolabelled medicine accumulates in the lymph nodes around the tumor, making them visible to a special camera. In this way it is possible to detect the presence of tumor cells in the lymph nodes.
What benefit has Lymphoseek - tilmanocept shown during the studies?
The benefits of Lymphoseek have been demonstrated in two main studies, in which the lymph nodes of 311 patients with breast cancer or melanoma were first mapped with Lymphoseek and then with another method involving the use of a dye called “dye vital blue ”. The blue dye is used during surgery to stain the lymph nodes, to allow detection and proceed with the search for tumor tissue. In these two studies the doctors were able to detect a higher number of sentinel lymph nodes with Lymphoseek than with the blue dye: almost all the lymph nodes detected with the blue dye (98% in one study and 100% in the other study) were also detected with Lymphoseek, while only about 70% and 60%, respectively, of the lymph nodes detected with Lymphoseek were identified with the blue dye. In a third study in patients with neck and head cancer, including oral carcinoma, Lymphoseek was used to detect sentinel lymph nodes before surgical removal of the lymph nodes. Lymphoseek has identified almost all patients (38 out of 39) with tumor lymph nodes.
What is the risk associated with Lymphoseek - tilmanocept?
The most common side effects with Lymphoseek (which may affect less than 1 in 100 people) observed in clinical studies are pain and irritation at the injection site. Other side effects were uncommon and were mild and of short duration. For the full list of all side effects and restrictions with Lymphoseek, see the package leaflet.
Why has Lymphoseek - tilmanocept been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that the studies showed that the use of Lymphoseek allowed a higher detection rate of sentinel lymph nodes compared to the use of the vital blue dye. Given the importance of localizing lymph nodes in the treatment of tumors and considering that the side effects observed with Lymphoseek are manageable, the committee decided that the benefits of the medicine outweigh the risks and recommended that they be approved for use in the EU .
What measures are being taken to ensure the safe and effective use of Lymphoseek - tilmanocept?
A risk management plan has been developed to ensure that Lymphoseek is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lymphoseek, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information is available in the summary of the risk management plan.
More information on Lymphoseek - tilmanocept
On 19 November 2014, the European Commission issued a marketing authorization for Lymphoseek, valid throughout the European Union. For the full version of the EPAR and the summary of the Lymphoseek risk management plan, consult the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Lymphoseek therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2014.
