Lymphoseek: Newly approved for oral cavity cancer, more expansion expected

Following Friday's FDA-approval, Lymphoseek, otherwise known as technetium Tc-99m tilmanocept, is now available for use in sentinel lymph-node mapping of patients with cases of head and neck cancer. Producer Navidea Biopharmaceuticals, based in Dublin, Ohio, held a teleconference for stakeholders yesterday to discuss the expanded approval.

Lymphoseek was first green-lighted in March of last year for sentinel lymph-node mapping of breast cancer and melanoma, but now clinicians can use the agent for head and neck cancer. The new rule applies specifically to oral cavity carcinoma and reimbursement for the procedure is set using codes already in place.

"The standard of care for these patients has been elective neck dissection wherein 30 or more lymph nodes are surgically removed, often resulting in debilitating post-procedural side-effects such as lymphedema, significant pain, loss of sensory perception and tremendous disfigurement potentially requiring extensive reconstructive surgery," said Michael M. Goldberg, MD, interim chief executive officer for Navidea, during the conference. "Lymphoseek now offers certain patients the option of undergoing a sentinel lymph node mapping procedure using the only FDA approved product for these procedures thus sparing them from unnecessary surgery and potentially debilitating side-effects."

Goldberg went on to discuss the findings of the phase III clinical trial leading up to Lymphoseek's newest approval. The data showed that sentinel lymph node mapping with Lymphoseek would have led to the surgical removal of about four lymph nodes versus the removal of 38 nodes using the standard. Officials discussed that European approval has not yet been achieved for this application.

“Our community eagerly welcomes a diagnostic aid such as Lymphoseek that may allow for a less invasive surgical procedure for patients with oral, head, and neck cancers,” said Nancy Leupold, founder and president of Support for People with Oral, Head, and Neck Cancer, in an official statement. “According to the National Cancer Institute, oral, head, and neck cancers account for approximately three percent of all malignancies in the United States, however, post-procedural side effects are more severe than with many other types of cancer. Significant changes in a patient's facial and neck appearance may be present. In addition, a patient may have difficulty with chewing, swallowing, smelling, tasting, speaking and hearing in addition to dental problems."

Navidea has announced a supplemental new drug application currently being reviewed by the FDA for expanded utilization of Lymphoseek. The scheduled review date is October 16, 2014.