Neoprobe Submits New Drug Application for Lymphoseek
10 Août 2011 - 10:05PM
Business Wire
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.i
“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
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