October 16, 2014 — Navidea Biopharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications.
Lymphoseek is now indicated for:
- Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management; and
- Guiding sentinel lymph node biopsy (SLNB) using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity, breast cancer or melanoma.
The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging, known as lymphoscintigraphy, to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek is the first and only FDA-approved radiopharmaceutical agent for sentinel lymph node detection, is the only FDA-approved agent for lymphatic mapping of solid tumors and will be immediately available using existing reimbursement codes for this expanded population of cancer patients.
“Based on our clinical experience in melanoma and head and neck cancers, Lymphoseek appears to be an effective agent for cancer staging to guide pre- and intra-operative patient management and post-surgical treatment, thereby avoiding unnecessary surgical interventions, reducing surgical time and limiting potential complications with associated morbidity,” commented Stephen Y. Lai, M.D., Ph.D., FACS, associate professor, Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center. “The ability of Lymphoseek to accurately identify sentinel lymph nodes in patients, demonstrated in clinical evidence from more than 500 patients, may not only improve diagnostic accuracy but also enable more efficient and appropriate patient care and provide us with greater precision during surgery to detect lymph nodes with the highest likelihood of harboring tumor metastases.”
“The success of lymphatic mapping and sentinel lymph node biopsy is dependent upon a radiopharmaceutical’s ability to concentrate in the lymph nodes most likely to contain cancer,” said H. William Strauss, M.D., attending physician emeritus, Molecular Imaging and Therapy Service at Memorial Sloan-Kettering Cancer Center. “Lymphoseek, with its specifically-designed ability to target molecular markers in tumor-draining lymph nodes, has shown through clinical studies in breast cancer, melanoma and certain head and neck cancers, to possess a high degree of sensitivity and accuracy. Based on the reliable performance of Lymphoseek as demonstrated in these tumor types, this approval opens up potential diagnostic imaging opportunities broadly across all forms of solid tumors.”
The expanded approval is supported by data from Navidea’s combined analysis of Lymphoseek’s pivotal prospective Phase 3 data in melanoma, breast cancer and certain head and neck cancers from more than 500 subjects. An integrated analysis of data from all three studies showed positive diagnostic performance of Lymphoseek across the solid tumor types studied. The findings indicate that Lymphoseek accurately identified lymph nodes for assessment in the trial subjects, and is likely to be predictive of overall node pathology status. 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).
In the approval action letter, the FDA also outlined a post-marketing requirement for initiation of a pediatric study in solid tumor cancer with a target date for submission in 2018.
For more information: www.lymphoseek.com