FDA approve Lymphoseek to evaluate head and neck cancer

Source: www.medicalnewstoday.com Author: Catharine Paddock PhD The US Food and Drug Administration have given the OK for doctors to use Lymphoseek - a radioactive diagnostic imaging agent - to evaluate the spread of squamous cell carcinoma in the body's head and neck region. Lymphoseek (technetium 99m tilmanocept) Injection was approved by the Food and Drug Administration (FDA) in 2013 to help doctors identify lymph nodes closest to primary tumors in patients with breast cancer and melanoma. The receptor-targeted lymphatic mapping agent is marketed by Navidea, a biopharma company based in Dublin, OH. Identification of lymph nodes in cancer is important because they filter fluid that drains from tissue. If this tissue is cancerous then the fluid will contain cancer cells, and testing lymph nodes - via biopsy - for presence of cancer cells helps determine if the cancer has spread. The approval of Lymphoseek for use in head and neck cancer patients means doctors will be able to use the agent to guide testing of sentinel nodes - lymph nodes closest to a primary tumor - allowing for the "option of more limited lymph node surgery in patients with sentinel nodes negative for cancer," say the FDA. In a clinical trial, researchers found that "Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system." Dr. Libero Marzella, director of the Division of Medical Imaging Products in the federal agency's Center for Drug Evaluation and Research, says: "For some patients with head and [...]

Lymphoseek designated fast track status in head and neck cancer

Source: www.empr.com Author: press release Navidea announced that the FDA has granted Fast Track designation to Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer. Lymphoseek Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymposeek Injection was evaluated in a prospective, open-label, multicenter, within-patient study (NEO3-06). It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes following a multiple level lymph node dissection. A minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease was required. Thirty nine subjects out of over 80 subjects enrolled were determined to have pathology-positive lymph nodes. Navidea intends to file the supplemental New Drug Application (sNDA) for Lymphoseek before the end of 2013. Lymphoseek is already approved for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma.

2013-12-11T04:54:14-07:00December, 2013|Oral Cancer News|

Neoprobe enrolling patients in head and neck cancer trial

Source: www.medcitynews.com Author: Brandon Glenn Cancer diagnostics company Neoprobe is continuing to enroll patients in a phase 3 head and neck cancer clinical trial of its radiopharmaceutical Lymphoseek. The trial is aimed at expanding Lymphoseek’s label to cover procedures known as sentinel lymph node biopsies, CEO Mark Pykett said in a conference call with investors. The sentinel lymph node is the first lymph node to which cancer is likely to spread from the primary tumor, according to the National Cancer Institute. Neoprobe on Wednesday announced that it had filed a New Drug Application for Lymphoseek, but that filing sought labeling for a different clinical indication: intraoperative lymphatic mapping, which is a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified to determine if cancer has spread to the lymph nodes. That procedure is typically used for patients with breast cancer or melanoma. Neoprobe’s head and neck cancer clinical trial is expected to enroll 200 patients. The study’s estimated completion date is March 2013, according to information the company has filed with the National Institutes of Health. In addition to expanding Lymphoseek’s label, Neoprobe is looking to strike deals with potential European and Asian distribution, and sales and marketing partners for the drug. Cardinal Health is handling U.S. distribution and sales and marketing of Lymphoseek. Lymphoseek has not been approved for sales anywhere in the world, but could obtain approval in the U.S. by the middle of next year. Here’s how Pykett laid out his [...]

Go to Top