History of Approvals

2014

  • Lymphoseek received European Commission approval in SLN detection for melanoma, breast and oral cavity cancer head and neck.  Read more

  • Lymphoseek sNDA approved for lymphatic mapping of all solid tumors where lymphatic mapping is a component of surgical management and added guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer and melanoma. Read more

  • Lymphoseek sNDA approved for guiding Sentinel Lymph Node (SLN) Biopsy in squamous cell carcinoma of the oral cavity. Read more:  

2013

  • Lymphoseek (technetium Tc 99m tilmanocept) injection approved by the US FDA for lymphatic mapping in breast cancer and melanoma. Read more

Lymphoseek Indication and Important Safety Information

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%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: 

WWW.LYMPHOSEEK.COM