Navidea Biopharmaceuticals Inc (NAVB) has launched its lymphatic mapping agent Lymphoseek for use in breast cancer and melanoma with partner Cardinal Health Inc (CAH), and is looking at potential to expand the label for use in other areas after promising results shown in head and neck cancer, says Dr. Mark J. Pykett, CEO of Navidea Biopharmaceuticals Inc.
“Lymphoseek was approved for use in lymphatic mapping procedures in breast cancer and melanoma by the FDA in mid-March, and we launched the agent commercially in early May with our partner Cardinal Health in the United States. Cardinal Health is the leading distributor of radiopharmaceuticals in the U.S., and they are really the best-suited partner to make Lymphoseek a commercial success,” Dr. Pykett said.
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Upon approval, Lymphoseek had been through a number of rigorous clinical studies that demonstrated its ability to pinpoint and accurately identify key lymph nodes, Dr. Pykett said. Those lymph nodes are then biopsied to determine if the cancer has spread. NAVB is now looking forward into the possibility of expanding the label into other types of cancer after strong data from a third Phase III study in patients with head and neck cancer.
“The results in this study, called the NEO3-06 study, are very compelling. In this study…we showed that Lymphoseek had a very high sensitivity of about 97.5% with a very low false negative rate of about 2.5% in identifying lymph nodes that contain cancer in patients where the disease has begun to spread from the primary tumor site into the lymphatic system. That’s an astonishingly low false negative rate that really shows the ability of Lymphoseek to identify the right lymph nodes and be able to help determine if the cancer has spread into the lymphatic system,” Dr. Pykett said. “We are now assessing those data with the possibility of submitting an sNDA, or supplemental NDA, to the FDA later this year, which would potentially allow us to expand the label for Lymphoseek into other kinds of cancers such as head and neck cancer.”
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