The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' Lymphoseek (technetium Tc 99m tilmanocept) 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.
Lymphoseek is a receptor targeted radiopharmaceutical product, which is developed to identify these lymph nodes, which have the highest probability of holding cancer and thereby assist physicians in the staging of such patients.
Navidea president and CEO Mark Pykett said with the FDA approval for Lymphoseek the firm believes there the scope to advance in the field of precision diagnostics.
"Our vision is to improve diagnostic accuracy, clinical decision-making and patient care. We are gratified that our scientific achievements may benefit thousands of patients diagnosed with breast cancer and melanoma each year," Pykett added.
"We look forward to continuing the development of Lymphoseek into additional indications and to progressing our oncology and neurology pipeline."
The approval of Lymphoseek was 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% of resected, histology-confirmed lymph nodes.
Navidea claims that 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 US on an exclusive basis by Cardinal Health.
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 US.
