Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that its New Drug Application (NDA) for Lymphoseek ® (tilmanocept) has been accepted for review by the U.S. Food and Drug Administration (FDA). Neoprobe submitted the Lymphoseek NDA on August 10, 2011.
Neoprobe seeks U.S. 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. According to the American Cancer Society, approximately 230,000 new cases of breast cancer and 70,000 new cases of melanoma are expected to be diagnosed in the United States in 2011. 1 The Lymphoseek NDA has proposed use of the agent in anatomic delineation of lymphatic tissue.
“The acceptance of the Lymphoseek NDA filing marks a critical milestone for the clinical and regulatory development of this agent. Lymphoseek has undergone study in two prospective, well- controlled and designed Phase 3 clinical trials under the direction of nearly 30 investigators in more than 500 patients,” said Rodger A. Brown, Vice President, Regulatory Affairs and Quality Assurance, of Neoprobe. “We look forward to working in collaboration with the FDA to prepare for its pending review of the NDA.”
About the Lymphoseek NDA SubmissionThe NDA submission for Lymphoseek includes results from two Phase 3 studies of Lymphoseek, NEO3-05 and NEO3-09, performed in patients with either breast cancer or melanoma. The primary endpoint for both the NEO3-05 and NEO3-09 studies was the concordance (or the rate of agreement) on a lymph node count basis of Lymphoseek with vital blue dye, a long-standing, FDA-approved, on-label agent for lymphatic mapping and appropriate “Truth Standard” comparator for registration purposes. In both of the Phase 3 studies (NEO3-05, NEO3-09), the concordance of Lymphoseek to vital blue dye was highly statistically significant (p<0.0001). Lymphoseek met all primary and secondary endpoints across both studies.