FDA Approves New Indication For Navidea's Lymphatic Mapping Agent

(RTTNews) - Navidea Biopharmaceuticals Inc. (NAVB) has won FDA approval for the expanded use of its lymphatic mapping agent - Lymphoseek - for guiding sentinel lymph node (SLN) biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. This approval marks the second indication for Lymphoseek in the U.S.

Lymphoseek Injection, a radioactive diagnostic imaging agent, was initially approved by the FDA in March 2013 for locating lymph nodes in breast cancer or melanoma patients who are undergoing sentinel lymph node biopsy.

Lymphoseek was launched in the U.S. in May 2013. Navidea has a distribution partnership with Cardinal Health for the sale and distribution of Lymphoseek in the U.S. The company began reporting revenue from Lymphoseek beginning in the second quarter of 2013.

Navidea's share of product revenue from sales of Lymphoseek was $128,000 in Q2, 2013; $144,000 in Q3, 2013; $343,000 in Q4, 2013 and $627,000 in Q1, 2014.

The company has an additional Supplemental New Drug Application under review at the FDA seeking approval of Lymphoseek with more flexible and extended utilization practices, and has a decision date set for October 16, 2014.

Navidea will host a conference call on Monday, June 16, 2014 at 08:30 a.m. EDT to discuss the FDA approval for the expanded use of Lymphoseek.

NAVB has traded in a range of $1.11 to $3.31 in the last 1 year. The stock was up 1.15% to $1.76 in after-hours trading.