Lymphoseek FDA approved for lymphatic malignancy in all solid tumors

Navidea Biopharmaceutical’s supplemental new drug application for sentinel lymph-node mapping agent Lymphoseek (technetium Tc 99m tilmanocept) has now been approved for detection of lymph node involvement in all solid tumors, the company announced today.

This green light also applies to sentinel lymph node mapping of breast cancer and melanoma. Navidea, based in Dublin, Ohio, estimates that the expanded approval could impact clinical management of up to 1.2 million cancer patients in the U.S. every year.

“Lymphoseek is the now the only agent approved by the FDA for lymphatic mapping across solid tumors when used as a component of surgical management,” said Michael Goldberg, MD, Navidea’s interim chief executive officer, in a press release. “This significantly expands the potential market for Lymphoseek and materially enhances the company’s ability to promote the use of Lymphoseek in solid tumor cancers where assessment of lymphatic involvement is critical to properly staging the disease, especially colorectal, gynecological, lung and prostate cancers.”

The new indications include lymphatic mapping with handheld gamma counter at primary solid tumor sites as a part of intraoperative cancer management and for sentinel lymph node mapping with gamma counter in squamous cell carcinoma, melanoma and breast cancer.

The FDA is stipulating documentation of the initiation of a pediatric study involving Lymphoseek in solid tumors in 2018. Regulatory reimbursement codes are already available for the expanded application of the drug.