Gamma camera probe developer Neoprobe has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its Lymphoseek radiopharmaceutical for determining whether cancer has spread to the lymph nodes.
Lymphoseek uses a process that Neoprobe calls intraoperative lymphatic mapping (ILM), in which the lymph nodes draining the area around a tumor are identified and biopsied to see if cancer has spread. Neoprobe's NDA includes results from two phase III clinical trials that compared Lymphoseek to vital blue dye, a longstanding agent for lymphatic mapping.
Neoprobe said the studies demonstrate that Lymphoseek has a concordance rate with blue dye of 99.99% on both a per-node and per-patient basis. In more than 500 patients who received Lymphoseek to date, no drug-related serious adverse events have been reported, the company added.
