Neoprobe Corporation (AMEX: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced it has submitted a New Drug Application (NDA) for Lymphoseek
(tilmanocept) to the U.S. Food and Drug Administration (FDA). Neoprobe seeks clearance to market Lymphoseek in the United States 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 United States in 2010.
“The Lymphoseek NDA marks a significant clinical and regulatory milestone for our novel, receptor-targeted radiopharmaceutical agent, Lymphoseek, that has undergone extensive clinical evaluation over many years by nearly thirty investigators in over five hundred patients,” said Dr. Frederick O. Cope, Neoprobe Senior Vice President, Pharmaceutical Research and Clinical Development, of Neoprobe.
“We look forward to continuing to work closely with the FDA to shepherd the Lymphoseek NDA through its review process and to approval,” said Rodger A. Brown, Neoprobe Vice President, Regulatory Affairs and Quality Assurance.
About the Lymphoseek NDA Submission
The NDA submission for Lymphoseek includes results from two Phase 3 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.
The Concordance Rate was analyzed on both a per-node and per-patient basis. On a per node basis, a meta-analysis of the results of the two Phase 3 studies (NEO3-05, NEO3-09) yielded a Concordance Rate of 99.99%, a highly statistically significant result (p<0.0001). A meta-analysis of the results of the two Phase 3 studies (NEO3-05, NEO3-09) yielded a per-patient Concordance Rate of 99.99%, again a highly statistically significant result (p<0.0001).