Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, announced it has submitted a New Drug Application (NDA) for Lymphoseek (tilmanocept) to the US 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 tumour are identified and biopsied to determine if cancer has spread to the lymph nodes. In the US 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.
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.
The Concordance Rate was analysed 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 III studies (NEO3-05, NEO3-09) yielded a per-patient Concordance Rate of 99.99%, again a highly statistically significant result (p<0.0001). In over 500 subjects receiving Lymphoseek to date, including those studied as a part of them NEO3-05 and NEO3-09 trials, no drug-related serious adverse events or clinically significant drug-related adverse events have been reported.
“This NDA submission is an important step toward improving the lives of patients who undergo lymphatic mapping procedures for potential diagnosis of the spread of solid tumor cancers,” said Dr Mark J Pykett, Neoprobe president and CEO. “We look forward to an efficient review process with the FDA and moving this important agent to commercialization. We remain confident – as we have throughout the entire clinical evaluation and regulatory process – that the two phase III trials supporting drug registration were designed appropriately, that they met all of their primary and secondary endpoints, and that Lymphoseek is safe, all of which support the pathway for Lymphoseek to achieve regulatory approval and commercial success in the near future.”
Lymphoseek is a proprietary radioactive diagnostic tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as Intraoperative Lymphatic Mapping. Two phase III multi-centre clinical trials (www.clinicaltrials.gov, trial registration numbers NCT00671918 and NCT01106040) for Lymphoseek in patients with breast cancer or melanoma have concluded. A third phase III clinical study to evaluate the efficacy of Lymphoseek as a sentinel lymph node tracing agent in patients with head and neck squamous cell carcinoma is currently ongoing (www.clinicaltrials.gov, trial registration number NCT00911326).