Lymphoseek gains EU approval for sentinel node mapping in select cancers

Navidea Biopharmaceuticals announced today that technetium-99m tilmanocept (Lymphoseek) has been approved by the European Commission for the detection of sentinel lymph node involvement in primary breast cancer, melanoma and localized squamous cell carcinoma.

The Dublin, Ohio, based radiopharmaceutical company is having a good year, as this announcement comes shortly after Navidea’s Oct. 15 announcement that Lymphoseek garnered FDA approval for the sentinel node mapping in all solid tumors. This is in addition to previous approvals for certain head and neck cancers, as well as breast, melanoma and squamous cell carcinomas in the U.S. 

“This is yet another important milestone achieved by Navidea in our global commercialization of Lymphoseek and reaffirms our commitment to improving the lives of oncology patients worldwide,” said Rick Gonzalez, Navidea’s CEO. “We are excited that Lymphoseek is the first agent centrally approved in Europe for Sentinel Lymph Node (SLN) detection.  It is differentiated in its ability to reliably and accurately locate SLNs to effectively stage cancer and inform post-surgical treatment. We look forward to making Lymphoseek available throughout Europe with initial launches into certain major markets planned for later in 2015. We will be sharing more details about our commercialization plans in the coming months.”

With this approval, Lymphoseek will now be an option made available for about 367,000 new cases of breast cancer; 83,000 new cases of melanoma; and 55,000 cases of oral cavity cancers diagnosed in Europe ever year, according to Navidea officials.