FDA approves Lymphoseek to help doctors target head, neck cancer locations
- Lymphoseek (technetium 99m tilmanocept) injection will help doctors determine the extent of squamous cell carcinoma in the head and neck region.
- Lymphoseek was approved in 2013 to help detect lymph nodes in patients with breast cancer and melanoma.
- Lymphoseek, which is marketed by Navidea Pharmaceuticals in Ohio, has been proven safe and effective in 85 patients with squamous cell carcinoma.
Lymphoseek has a great deal of utility for physicians who want to target sentinel lymph nodes—the cells closest to the original tumor. Doing so can help them be more precise in determining where the cancer is, which makes lymph-node removal surgery more limited and targeted.
In March 2013, Navidea received approval for Lymphoseek to be used for lymphatic mapping procedures for breast cancer and melanoma. Then in December 2013, FDA granted the company fast-track status as it pursued approval for use of its diagnostic product in patients with squamous cell carcinoma. Next up the company will investigate the use of Lymphoseek in identifying location of cancerous cells in patients with other solid tumors, such as prostate cancer, thyroid cancer, lung cancer and colorectal cancer.
- The Wall Street Journal FDA Grants Fast-Track Status to Navidea's Lymphoseek
- Medical News Today FDA approve Lymphoseek to evaluate head and neck cancer