Neoprobe Receives FDA Acceptance of Lymphoseek® (tilmanocept) New Drug Application
October 19 2011 - 5:37PM
Business Wire
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 Submission
The 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
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