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June 16, 2014

Navidea’s sNDA for Lymphoseek injection gets FDA approval

The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals' supplemental new drug application (sNDA) for expanded use of Lymphoseek injection in head and neck cancer sentinel lymph node biopsy.

The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals’ supplemental new drug application (sNDA) for expanded use of Lymphoseek injection in head and neck cancer sentinel lymph node biopsy.

Navidea Biopharmaceuticals’ sNDA has been approved by the FDA for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection, indicated for guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity.

In March 2013, Lymphoseek injection was approved for lymphatic mapping in breast cancer and melanoma patients.

"Navidea intends to continue its investment in Lymphoseek to further expand its use in other types of cancer, where current alternatives are neither efficient nor effective."

The FDA has approved the expanded use of Lymphoseek injection based on data from the NEO3-06 prospective Phase III study that showed with statistical significance the ability of Lymphoseek to correctly identify patients with pathology-positive lymph nodes compared with multiple level lymph node dissection and pathology assessment.

According to Navidea Biopharmaceuticals, the study findings indicate that Lymphoseek accurately identified sentinel lymph nodes in the trial subjects for assessment, and is likely to be predictive of overall node pathology status.

Navidea Biopharmaceuticals interim CEO Michael Goldberg said that with this approval, Lymphoseek is now the only FDA-approved diagnostic agent with a label for guiding sentinel lymph node biopsy procedures and will be immediately available with the existing reimbursement codes for this expanded population of cancer patients.

"Navidea intends to continue its investment in Lymphoseek to further expand its use in other types of cancer, where current alternatives are neither efficient nor effective," Goldberg said.

"We believe Lymphoseek can play a critical role in the staging and treatment of cancer, with potential for additional procedural cost savings."

Lymphoseek injection is a receptor-targeted lymphatic mapping agent. The FDA granted fast-track designation to the Lymphoseek application in December 2013, with priority review in February 2014.

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