Neoprobe Corporation, a developer of oncology surgical and diagnostic products, announced it has submitted a New Drug Application (NDA) for Lymphoseek (tilmanocept) to the FDA for 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., ILM is performed primarily for patients with breast cancer and melanoma. The NDA submission for Lymphoseek includes results from two Phase 3 trials of Lymphoseek, NEO3-05 and NEO3-09.
Lymphoseek is a proprietary radioactive diagnostic tracing agent developed for use in connection with gamma detection devices in ILM.
For more information call (800) 793-0079 or visit www.neoprobe.com.