Navidea Biopharma (NAVB +4.2%) says the FDA granted a priority review for an expanded use of its Lymphoseek drug for sentinel lymph node detection in patients with head and neck cancer.
The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options; Lymphoseek is already approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
In other company news, NAVB says it will collaborate with the University of San Francisco "on a clinical study to evaluate, for the first time, the use and performance of technetiumlabeled tilmanocept in patients with Kaposi Sarcoma." (PR)
Navidea BioPharma (NAVB) +7.4% premarket following release of Phase 3 clinical trial data for its Lymphoseek injection in patients with head and neck squamous cell carcinoma.
The now-completed full study indicates Lymphoseek met all pre-specified study endpoints, including sensitivity, negative predictive value and overall accuracy relative to the pathology status of non-SLNs.