Neoprobe, a developer of oncology surgical and diagnostic products, has submitted a new drug application (NDA) for Lymphoseek (tilmanocept) to the FDA.
The Dublin, Ohio-based company is seeking clearance to market Lymphoseek for use in Intraoperative Lymphatic Mapping (ILM), a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes.
In the U.S. today, ILM is performed primarily for patients with breast cancer and melanoma. According to the American Cancer Society, approximately 209,000 new cases of breast cancer and 68,000 new cases of melanoma were diagnosed in the U.S. in 2010.
The novel, receptor-targeted radiopharmaceutical agent, Lymphoseek, has undergone extensive clinical evaluation by nearly 30 investigators in more than 500 patients, according to Frederick O. Cope, MD, Neoprobe's senior vice president of pharmaceutical research and clinical development.
The NDA submission for Lymphoseek includes results from two phase III trials of Lymphoseek, NEO3-05 and NEO3-09. The primary endpoint for both the NEO3-05 and NEO3-09 trials was the comparison (the Concordance Rate, or the rate of agreement) of Lymphoseek versus vital blue dye, a long-standing, FDA-approved, on-label agent for lymphatic mapping and appropriate requisite “Truth Standard” comparator for registration purposes.