Navidea Biopharmaceuticals is launching Lymphoseek, its diagnostic agent used to check for cancer spread, with medical affairs, promotional education and CME aimed at the nuclear medicine community.
The injection, green-lighted by FDA in March, is the first agent in 30 years to be approved for lymphatic mapping—basically analyzing lymph nodes for signs that a cancer has metastasized. It’s sanctioned for use in breast cancer and melanoma. Sulfur Colloid, made by contract manufacturer Pharmalucence, is the only other radiopharmaceutical approved for lymph node localization in these cancers.
Lymphoseek will be sold and distributed in the US exclusively by Cardinal Health through its Nuclear Pharmacy Services. Navidea will deploy medical science liaisons (MSLs) to educate about lymphatic mapping and sentinel node biopsy to hospitals that practice nuclear medicine.
“We have aspirations to participate in the commercial side of the business, but only from a medical-education point of view,” said Thom Tulip, EVP, chief business officer for Navidea. Tulip said the MSL approach “lets us leverage what we learn in the clinic and pharmacy and apply it to not only educate customers to drive adoption [but] also to lift the overall top-line to make the market grow.”
He said Navidea’s goal involves expanding Lymphoseek’s market to other cancer types that lend themselves to lymphatic mapping. “The mechanism of action is not cancer-specific,” added Tulip, but may apply to “any solid tumor that drains into the lymphatics.”