The Food and Drug Administration has expanded the approved use of Lymphoseek (technetium Tc 99m tilmanocept) Injection for lymphatic mapping in all solid tumors. Sentinel lymph node detection for breast cancer and melanoma has also been added to the approved indications.
Lymphoseek is the first and only FDA-approved radiopharmaceutical agent for sentinel lymph node detection, it is the only FDA-approved agent for lymphatic mapping of solid tumors, and it will be immediately available using existing reimbursement codes for this expanded population of cancer patients, a news release from the manufacturer, Navidea, notes.
Lymphoseek was first approved for use in patients with breast cancers or melanomas who are undergoing surgery to remove tumor-draining lymph nodes to help doctors locate lymph nodes (OT 4/10/13 issue). And earlier this year it was approved to guide sentinel lymph node testing for patients with head and neck cancers to help determine the extent of the spread of the tumor (OT 8/25/14 issue), and it received orphan drug designation for that indication (OT 10/25/14 issue).
Lymphoseek is now indicated 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; and
* 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.
The FDA has also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging-i.e., lymphoscintigraphy-to enable preoperative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures.
Lymphoseek's expanded approval is based on Phase III data in melanoma, breast cancer, and head and neck cancers of approximately 500 patients. Analysis from the three studies showed positive diagnostic performance of Lymphoseek across the solid tumor types studied and, to date, no clinically significant drug-related adverse reactions have been reported.
The agent has no contraindications, and the most common adverse reactions have been injection site irritation and/or pain.
In the approval action letter, the FDA also outlined a post-marketing requirement for initiation of a pediatric study in solid tumor cancer, and set a target date for submission in 2018, according to the news release.