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news.Navidea Biopharmaceuticals has received marketing authorization from the European Commission for Lymphoseek (technetium Tc 99m tilmanocept) injection 250mg kit.
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The kit has been designed for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma or localized squamous cell carcinoma of the oral cavity
The sentinel node detection label in European Union (EU) will now allow Lymphoseek to be used in about 367,000, 83,000 and 55,000 new cases of breast cancer, melanoma and oral cavity cancers diagnosed in Europe annually, respectively.
Navidea CEO Rick Gonzalez said: "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."
In the US, Lymphoseek is approved for use in lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
It will also be used to guide Sentinel Lymph Node Biopsy (SLNB) using a handheld gamma counter in patients with node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Lymphoseek is a new receptor-targeted, small-molecule radiopharmaceutical, and is the first and only FDA-approved receptor-targeted lymphatic mapping agent.
The product is used to evaluate lymphatic basins that may have cancer involvement in patients with breast cancer, melanoma and head and neck cancer patients with oral cavity carcinoma.
The injection is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
Image: Lymphoseek injection will now be used in about 367,000, 83,000 and 55,000 new cases of breast cancer, melanoma and oral cavity cancers. Photo: courtesy of Baitong333/ freedigitalphotos.net.