April 1, 2013 — Navidea Biopharmaceuticals Inc. announced U.S. Food and Drug Administration (FDA) approval of Lymphoseek (technetium Tc 99m tilmanocept) Injection, a novel product indicated for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek is a receptor targeted radiopharmaceutical designed to identify these lymph nodes, which have the highest probability of harboring cancer and thereby assist physicians in the staging of such patients.
Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. Accurate staging of lymph nodes is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 232,000 new cases of breast cancer and 77,000 new cases of melanoma are expected to be diagnosed in the United States in 2013.
“We recommend lymphatic node mapping and sentinel node biopsy for patients with early stage breast cancer and in select cases of ductal carcinoma in situ,” said Anne Wallace, M.D., professor of surgery, UC San Diego School of Medicine; director of the Breast Care Unit; UC San Diego Moores Cancer Center; and principal investigator for breast cancer in the Lymphoseek Phase 3 clinical trials. “The ability to reliably identify multi-node pathology-positive patients is important to optimize their post-surgery management and to spare certain patients from unnecessary surgery and potentially debilitating side effects. Products specifically designed to address reliable lymph node uptake and retention can provide significant clinical utility and help standardize the process of lymph node mapping.”
“Both the incidence rate and the death rate for melanoma continue to increase, in the United States and in many other parts of the world," said Vernon K. Sondak, M.D., chair, Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa Fla., and Principal Investigator for melanoma in the Lymphoseek Phase 3 clinical trials. "Most patients present with clinically localized disease, but microscopic metastases to the regional lymph nodes are common and are the major prognostic factor for these patients. Over the past 20 years, surgical staging of the regional nodes with intraoperative lymphatic mapping and sentinel node biopsy has emerged as the worldwide standard of care for patients with clinically node-negative intermediate and thick melanomas, and for selected patients with higher-risk thin primaries as well. New technologies offer the promise of improving intraoperative lymphatic mapping, allowing procedures to be done more quickly and potentially lessening the risk of misclassifying patients as node-negative when in fact their tumor has already spread to the regional nodes.”
The approval of Lymphoseek is based on data from more than 540 subjects receiving Lymphoseek. In pivotal Phase 3 studies that were conducted in 332 patients with either breast cancer or melanoma, Lymphoseek, on average, was present in 97 percent (range 94-100 percent) of resected, histology-confirmed lymph nodes. 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 percent).
“Our vision is to improve diagnostic accuracy, clinical decision-making and patient care. We are gratified that our scientific achievements may benefit thousands of patients diagnosed with breast cancer and melanoma each year. We look forward to continuing the development of Lymphoseek into additional indications and to progressing our oncology and neurology pipeline,” said Mark J. Pykett, V.M.D., Ph.D., president and CEO of Navidea.
Lymphoseek will be sold and distributed in the United States on an exclusive basis by Cardinal Health Inc. As part of the distribution agreement, Cardinal Health’s Nuclear Pharmacy Services business will be responsible for commercializing and dispensing Lymphoseek to health care professionals who are involved in lymphatic mapping. Navidea is also working to identify and partner with distributors in other markets outside of the United States. Navidea will play an ongoing role in commercial activities through focused deployment of medical science liaison and medical education activities. This is consistent with Navidea’s overall strategy to remain involved in market-based activities with its products while leveraging the extensive capabilities and infrastructure of partners around the world.