Lymphoseek, which is basically a diagnostic imaging agent that doctors use to determine the spread of squamous cell carcinoma in the neck and head region, has received approval from the FDA. Consequently, this will make it easier for doctors to map and identify sentinel lymph nodes (SLNs). Currently, doctors have to carry out invasive surgical procedures such as neck dissection to identify the same nodes. However, Lymphoseek makes the identification of such nodes much easier. Physicians will inject the drug into the area with a suspected tumor and then use a handheld radiation detector to find sentinel lymph nodes.
High Degree of Accuracy
During the phase 3 study, data collected from participants showed with statistical significance that Lymphoseek could identify patients with sentinel lymph nodes with a high degree of accuracy. For example, lymph node dissection identified 39 patients with pathology-positive nodes. Doctors monitoring participants who received Lymphoseek injections were able to identify 38 of the 39 patients with pathology-positive nodes. Prior to the approval of this new drug, doctors removed an average of 38 lymph nodes per patient. With Lymphoseek injections, doctors only remove an average of four lymph nodes per patient.
According to University of Miami School of Medicine’s Francisco J. Civantos, MD, physicians using neck dissection to identify SNLs treat up to 75% of patients with head and neck cancers. On the safety front, participants involved in clinical trials underwent rigorous tests including:
- Physical examinations
- Laboratory tests
- Electrocardiogram tests
The results did not show serious side effects. Moreover, there were no fatalities reported.
Lymphoseek is a new drug that promises to revolutionize the treatment of people with head and neck cancer. Take note that the FDA has approved Lymphoseek injections for patients with oral cavity, neck, head, melanoma, and breast cancers. The pharmaceutical company that produces this drug, Navidea, is working on a similar drug that doctors can use to diagnose and identify different types of cancer, including thyroid, prostrate, colorectal, and lung cancer.