September 29. 2014 — Navidea Biopharmaceuticals, Inc. has announced that that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for Lymphoseek 250 micrograms kit for radiopharmaceutical preparation (tilmanocept) in the European Union (EU). The recommendation is for Lymphoseek use 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 CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 28 countries of the European Union and generally follows the recommendations of the CHMP. Navidea expects the European Commission to issue its final decision on the marketing authorization for Lymphoseek later this year.
"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,” said Michael Goldberg, M.D., Interim CEO of Navidea. "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 United States and prepare to make the product available next year to physicians in Europe looking to provide the best care for their patients.”
“Current medical practices for head and neck cancers call for removal of large numbers of lymph nodes, lymph node dissection, even in patients without proven lymph node metastasis,” said Remco de Bree, M.D., Ph.D., Department of Otolaryngology-Head and Neck Surgery, VU University Medical Center, Amsterdam, The Netherlands. “Using the common practice of elective treatment of the neck, large numbers of patients undergo unnecessary extensive surgical procedures, which are associated with the risk of decreased shoulder function, decreased quality of life and increased costs. The practice of Sentinel Lymph Node Biopsy (SLNB) may offer a less invasive and equally predictive alternative for patient staging and directing adequate treatment of the neck. We welcome the addition of Lymphoseek in Europe as an approved sentinel lymph node detection agent with the potential to offer surgeons the ability to reliably and accurately guide SLNB procedures.”
The opinion of the CHMP was based on positive and consistent results from Lymphoseek’s three pivotal prospective Phase 3 studies in melanoma, breast cancer, and certain head and neck cancers and included associated analysis of the combined data from more than 500 subjects. All three studies showed positive diagnostic performance of Lymphoseek across the solid tumor types studied. To date, no clinically significant drug-related adverse reactions have been reported. Lymphoseek has no contraindications and the most common adverse reactions were injection site irritation and/or pain (<1%).
Lymphoseek is approved in the United States by the U.S. 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. Lymphoseek is also the subject of a supplemental New Drug Application (sNDA) currently under review by the FDA, related to broader and more flexible utilization in lymphatic mapping procedures.
For more information: www.lymphoseek.com