After winning a long-delayed FDA approval for Lymphoseek, Navidea ($NAVB) is working to get the diagnostic aid approved for head and neck cancers, touting positive top-line results from a Phase III trial.
Navidea is studying its imaging agent's ability to identify squamous cell carcinoma in the head and neck, evaluating Lymphoseek against the "gold standard" of nodal dissection, in which surgeons remove large portions of lymph node tissue. So far, Lymphoseek has excelled, Navidea says, meeting its primary endpoints with low rates of false negatives. And Navidea's method is easier on patients: The dissection procedure requires removing an average of 38 nodes, while Lymphoseek needed just four.
In light of the positive results, Navidea is considering closing the study early, and it plans to evaluate the full data set, present it at scientific meetings and consider a supplemental FDA filing to get Lymphoseek approved to diagnose head and neck cancer, CEO Mark Pykett said.
"These interim results are highly encouraging for this patient population who generally face extensive surgery to properly stage their cancer," Pykett said in a statement. "This study is part of Navidea's strategy to expand Lymphoseek utilization into multiple cancer types and assist physicians in improving the accuracy and extent of cancer diagnosis for their patients."
Last month, Navidea won FDA approval to use Lymphoseek to diagnose breast cancer and melanoma, a development months in the making after a third-party manufacturing issue led to a September rejection. But Navidea is hardly resting on that victory, working to expand Lymphoseek's adoption and develop imaging agents for Alzheimer's, Parkinson's and related dementia.
- read Navidea's statement