Lymphoseek lands FDA fast track

Navidea Biopharmaceuticals, makers of technetium-99m tilmanocept injection, otherwise known as Lymphoseek, announced FDA status for fast-track approval for the detection of lymph node involvement in head and neck cancers, according to a statement Dec. 10.

The drug has already been approved as of March this year for sentinel lymph node mapping in cases of breast cancer and melanoma. The new FDA designation comes as a result of additional data from the NEO3-06 phase III clinical trial about the drug’s ability to find sentinel lymph nodes in relation to nonsentinel lymph nodes in head and neck as well as intraoral squamous cell carcinoma.

“The Fast Track designation Navidea has received for Lymphoseek recognizes the significant unmet need that exists in the treatment of head and neck cancers and the important role that Lymphoseek can play in reducing or eliminating the need for debilitating elective neck dissection surgery,” said William J Regan, Navidea senior vice president for global regulatory strategy.

In the study, Lymphoseek was able to correctly detect cancerous lymph nodes in 38 out of more than 80 patients for a significant false positive rate of 2.56 percent. On average, Lymphoseek led to the removal of four lymph nodes versus the removal of 38 lymph nodes in multiple level nodal dissection. Results of lymphoscintigraphy were the same for both the day of and the day after injection. 

Navidea expects to file for supplemental New Drug Application (sNDA) before the new year. “After filing the sNDA, we look forward to working closely with the FDA to bring to market as quickly as possible an expanded label for Lymphoseek and what will be the first agent indicated in sentinel lymph node detection," added Regan.