Navidea Biopharmaceuticals said the U.S. Food and Drug Administration (FDA) has approved expanded indications for its Lymphoseek radiopharmaceutical. It has also hired pharmaceutical industry veteran Rick Gonzalez as CEO.
The FDA approval of Navidea's supplemental new drug application covers the use of Lymphoseek -- with or without scintigraphic imaging -- to facilitate preoperative imaging and lymphatic mapping in solid tumors. In addition, Lymphoseek can now be used to guide sentinel lymph node biopsy in patients with breast cancer and melanoma; previously, it was cleared only for guiding these biopsies in patients with clinically node-negative squamous cell carcinoma, according to the vendor.
The expanded indication for solid tumors will be available immediately using existing reimbursement codes; up to 1.2 million patients with solid tumors could benefit from this new use of Lymphoseek, according to Navidea.
In its approval action letter, the FDA included a postmarketing requirement for conducting a pediatric study in solid tumor cancer with a target submission date in 2018.
In executive news, Navidea appointed Rick Gonzalez as CEO, effective October 13. A 20-year pharmaceutical industry veteran, Gonzalez comes to Navidea from Spectrum Pharmaceuticals, where he served as vice president of global operations.
