Why LYMPHOSEEK®?

Only LYMPHOSEEK Is Specifically Designed for Targeted Lymphatic Mapping and Guiding SLN Biopsy1*

In October 2014, the FDA approved* the expanded use of LYMPHOSEEK as a lymphatic mapping agent for solid tumors where it is a component of the intraoperative procedure. To support the approval, the FDA evaluated a combined analysis of three pivotal Phase 3 studies in melanoma, breast cancer, and oral cavity squamous cell carcinoma (SCC), which established the efficacy of LYMPHOSEEK in solid tumors.

Realize the benefits of LYMPHOSEEK, the first and only agent specifically designed for targeted lymphatic mapping* and guiding sentinel lymph node (SLN) biopsy. LYMPHOSEEK represents a new class of receptor-targeted lymphatic mapping agents—one that is purpose-built for lymphatic mapping in patients with solid tumors.1

Given its consistent pharmacodynamics properties, LYMPHOSEEK may facilitate benefits such as predictable scheduling of lymphatic mapping procedures and efficient resource utilization.

A unique advancement

LYMPHOSEEK is the only agent designed, studied, proven, and FDA-approved for:

  • Lymphatic mapping in patients with solid tumors
  • Guiding sentinel lymph node biopsy in patients with breast cancer, melanoma, and squamous cell carcinoma of the oral cavity
  • Use with lymphoscintigraphy

Targets the CD206 receptor, a molecular marker for lymph nodes

  • LYMPHOSEEK allows for rapid transit from the injection site2
  • LYMPHOSEEK selectively and tightly binds to mannose receptors (CD206) located on the surface of macrophages and dendritic cells and accumulates in tumor- draining lymph nodes2,3

Precise lymph node detection

In patients with breast cancer, melanoma and SCC of the oral cavity…
  • 97% of patients had lymph nodes identified by LYMPHOSEEK2,4
  • LYMPHOSEEK demonstrated a low false negative rate for the identification of SLNs
  • Only 2.9% of patients with pathology-positive lymph nodes were not identified by LYMPHOSEEK2,4

Informs accurate staging and patient management

  • LYMPHOSEEK guides SLN biopsy in patients with breast cancer, melanoma, and squamous cell carcinoma of the oral cavity
  • LYMPHOSEEK provides actionable information to enhance pathological evaluation, leading to patient staging decisions

Enables evaluation



Frequently, there is more than one lymph node draining from a primary tumor that must be detected for diagnostic evaluation.5

 

 

References: 1. Wallace AM, Hoh CK, Ellner DO, et al. LYMPHOSEEK: A molecular imaging agent for melanoma sentinel node mapping. Ann Surg Oncol. 2007;14:913-21.2. LYMPHOSEEK Injection [prescribing information]. Dublin, OH: Navidea; September 2014. 3. Vera, DR, Tokin CA. Tilmanocept: a synthetic receptor-targeted molecule for sentinel lymph node mapping. International Atomic Energy Agency (IAEA) Publication 2014; Chapter X: In Press. 4. Data on file, Cardinal Health. 5. Lyman GH, Giuliano AE, Somerfield MR, et al. American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer. J Clin Oncol. 2005;23 (30):7703-7720.


*Indication

LYMPHOSEEK is a radioactive diagnostic agent indicated with or without scintigraphic imaging 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.
  • 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.

 

Important Safety Information

In clinical trials with LYMPHOSEEK, no serious hypersensitivity reactions were reported, however LYMPHOSEEK may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of LYMPHOSEEK, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of LYMPHOSEEK administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
Please see full Prescribing Information.

To report suspected adverse reactions, contact Cardinal Health at 1.800.618.2768 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.

The information on this web site is intended for use only by healthcare professionals in the United States.