FDA approves Lymphoseek Injection for use in lymphatic mapping

FDA approved (technetium Tc 99m tilmanocept (Lymphoseek, Navidea Biopharmaceuticals) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes.

Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumor. By surgically removing and examining the lymph nodes that drain a tumor, doctors can sometimes determine if a cancer has spread.

The FDA approval of Lymphoseek, an imaging drug that is designed to locate lymph nodes and assist doctors with identifying potential tumor draining lymph nodes in patients with breast cancer and melanoma can be viewed as another lifesaving measure in enhancing cancer treatment,” said Formulary Advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas. “This agent has the potential to help limit the widespread development of tumors through early identification and immediate removal that may become cancerous, or help to provide early treatment for those patients who are found to have cancerous tumors.”

Lymphoseek is an imaging drug that helps locate lymph nodes; it is not a cancer imaging drug. Lymphoseek is the first new drug used for lymph node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph node mapping include sulfur colloid (1974) and isosulfan blue (1981).

Lymphoseek’s safety and effectiveness were established in 2 clinical trials of 332 patients with melanoma or breast cancer. All patients were injected with Lymphoseek and blue dye, another drug used to help locate lymph nodes.

Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and/or Lymphoseek. Results showed Lymphoseek and blue dye had localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek.

“We recommend lymphatic node mapping and sentinel node biopsy for patients with early stage breast cancer and in select cases of ductal carcinoma in situ,” Anne Wallace, MD, professor of surgery, UC San Diego School of Medicine; director of the Breast Care Unit; UC San Diego Moores Cancer Center; and principal Investigator for breast cancer in the Lymphoseek phase 3 clinical trials, in a press release. “The ability to reliably identify multi-node pathology-positive patients is important to optimize their post-surgery management and to spare certain patients from unnecessary surgery and potentially debilitating side effects. Products specifically designed to address reliable lymph node uptake and retention can provide significant clinical utility and help standardize the process of lymph node mapping.”