FDA gave official permission for Lymphoseek (technetium 99, 99Ts) - radiodiagnostik injection intended for the detection of lymph vessels containing cancer cells. The product can be used to track the progress of breast malignancies and melanoma.
Lymph nodes lymphatic filtered liquid from body tissues. When this fluid comes from tissue containing tumor, she has cancer cells. By surgical removal of lymph nodes and study them under a microscope, doctors can determine whether they contain cancer cells if the tumor spreads.
Lymphoseek allows this analysis without removal of lymph nodes. It is the first product for mapping lymph nodes approved in 30 years. Administered through intravenous injection.
The safety and effectiveness of Lymphoseek is established by clinical study involving 332 patients with melanoma or breast cancer. Half of the participants were injected with Lymphoseek, and the other half - with blue dye, localized tumor cells in lymph nodes. Only in the study, surgeons remove lymph nodes of patients and analyze them under a microscope. The results indicate that dye and Lymphoseek found most of the nodes containing malignant cells, and that Lymphoseek found most of the lymph nodes that the dye can not identify.
In normal clinical setting, it is intended to be used without removing the lymph nodes.
During the study, the most common side effects are irritation and pain at the injection site.
The product is manufactured by Navidea Biopharmaceuticals, USA.