A European agency has recommended approval of radiopharmaceutical developer Navidea Biopharmaceuticals' Lymphoseek SPECT radiotracer for sentinel lymph node injection.
The positive opinion issued by European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended granting market authorization for the product, which is used in imaging and interoperative detection of sentinel lymph nodes draining a primary tumor in adults with breast cancer, melanoma, or head and neck oral cavity squamous cell carcinoma, Navidea said.
Final marketing approval will require authorization by the European Commission, which generally follows CHMP's recommendations, and Navidea said it is confident the agent will be in doctors' hands by next year.
Current medical practice requires the removal of large numbers of lymph nodes during surgery, which is invasive and risky for patients, who could suffer from a loss of shoulder function, reduced quality of life, and other side effects. By performing sentinel lymph node biopsy procedures with Lymphoseek, patients will have available an alternative that is less invasive and equally predictive for staging and managing disease, the firm said.