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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization for Navidea Biopharmaceuticals' Lymphoseek 250 micrograms kit for radiopharmaceutical preparation (tilmanocept) in the European Union (EU).
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The CHMP recommendation is for the use of Lymphoseek in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or head and neck oral cavity squamous cell carcinoma.
The European Commission will review the CHMP’s positive recommendation and is expected to issue its final decision on the marketing authorization for Lymphoseek later in 2014.
Navidea Interim CEO Michael Goldberg said: "This positive CHMP opinion moves Lymphoseek closer to becoming the first and only sentinel lymph node detection agent approved in all 28 member countries of European Union.
"We believe Lymphoseek is differentiated in its ability to reliably and accurately locate sentinel lymph nodes draining a tumor, to help more effectively stage cancer and inform post-surgical treatment, and to decrease patient morbidity.
"We are increasingly excited by the global opportunity for Lymphoseek as we build upon our approval in the U.S. and prepare to make the product available next year to physicians in Europe looking to provide the best care for their patients."
The CHMP positive opinion was based on positive and consistent results from Lymphoseek’s three pivotal prospective Phase III trials in melanoma, breast cancer, and certain head and neck cancers and included associated analysis of the combined data from more than 500 subjects.
The company said that all three trials showed positive diagnostic performance of Lymphoseek across the solid tumor types studied.
Lymphoseek (technetium Tc 99m tilmanocept) Injection is approved by the US Food and Drug Administration (FDA) for use in lymphatic mapping to assist in the detection of tumor-draining lymph nodes in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in certain oral cancer patients.