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FDA Approves Expanded Use of Tilmanocept for Lymphatic Mapping in Solid Tumors

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The U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application for the expanded use of technetium 99m tilmanocept (Lymphoseek Injection) for lymphatic mapping in solid tumors and for adding sentinel lymph node detection for breast cancer and melanoma to the approved indications.

Tilmanocept is now indicated for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management, as well as for guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node-negative squamous cell carcinoma of the oral cavity, breast cancer, or melanoma.

The FDA also allowed expanded utilization of tilamnocept with or without scintigraphic imaging, known as lymphoscintigraphy, to enable preoperative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures.

The expanded approval for tilmanocept is supported by data from a combined analysis of prospective phase III data in melanoma, breast cancer, and certain head and neck cancers from more than 500 subjects. An integrated analysis of data from all three studies showed positive diagnostic performance of tilmanocept across the solid tumor types studied and indicated that the agent accurately identified lymph nodes for assessment in the trial subjects, and is likely to be predictive of overall node pathology status. No clinically significant drug-related adverse effects have been reported.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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