Navidea Biopharmaceuticals landed FDA approval to expand use for its Lymphoseek imaging agent to help track cancers spreading in the head and neck.
Lymphoseek is the "1st and only FDA-approved radiopharmaceutical application for sentinel lymph node detection," according to Navidea, which originally won FDA approval for Lymphoseek in March 2013.
The regulatory nod expands marketing approval for Lymphoseek, which was originally indicated for use in patients with breast cancer and melanoma. Navidea may now also market the Lymposeek radioactive diagnostic agent to guide testing of "sentinel" lymph nodes, those that are closest to a primary tumor, in patients with squamous cell carcinoma of the oral cavity.
"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," the FDA said today. "By surgically removing and examining the lymph nodes that drain a tumor, a procedure called a biopsy, doctors can sometimes determine if a cancer has spread."
Doctors tracking the spread of cancers currently may biopsy as many as 30 or more lymph nodes at a time, with sentinel lymph node mapping stymied by the lack of an approved imaging agent, University of Texas MD Anderson Cancer Center’s Dr. Stephen Lai said on behalf of Navidea.
"This underscores the urgent need Lymphoseek may be able to address in improving the precision of SLN mapping and decreasing nodal excision to an average of only 4 lymph nodes," Lai said. "As a result, Lymphoseek offers the potential to more effectively stage certain cancers, direct post-surgical treatment and decrease patient morbidity."
"With this approval, Lymphoseek is now the only FDA-approved diagnostic agent with a label for guiding sentinel lymph node biopsy procedures and will be immediately available with the existing reimbursement codes for this expanded population of cancer patients," Navidea interim CEO Dr. Michael Goldberg said in prepared remarks. "Navidea intends to continue its investment in Lymphoseek to further expand its use in other types of cancer, where current alternatives are neither efficient nor effective. We believe Lymphoseek can play a critical role in the staging and treatment of cancer, with potential for additional procedural cost savings."