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.
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
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
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.