Navidea Biopharmaceuticals, Inc. (NAVB: Quote) Wednesday said it has received approval from the U.S. Food and Drug Administration, or FDA, for Lymphoseek injection, a novel product indicated for use in lymphatic mapping procedure.
The lymphatic mapping procedure identifies and biopsies lymph nodes that may contain tumor metastases and determine if cancer has spread beyond the primary tumor.
Accurate staging allows health care professionals to make right therapy decisions and patient prognosis, thereby avoiding risk of recurrence.
The approval of Lymphoseek were backed by results from the pivotal Phase 3 studies conducted in 332 patients with either breast cancer or melanoma.
In the trial, Lymphoseek was observed in 97 percent of resected, histology-confirmed lymph nodes. Lymphoseek did not show any contraindications, while most common adverse reactions were injection site irritation or pain.
Lymphoseek will be sold and distributed in the U.S. on an exclusive basis by Cardinal Health, Inc. As part of agreement, Cardinal Health's Nuclear Pharmacy Services will commercialize and dispense Lymphoseek to health care professionals who are involved in lymphatic mapping.
Navidea is also planning to identify and partner with distributors in other markets outside of the U.S.
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by RTT Staff Writer
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