Navidea Biopharmaceuticals ($NAVB) overcame an initial FDA rejection 6 months ago and finally obtained approval for Lymphoseek, a new radioactive diagnostic imaging agent designed to help map lymph nodes in breast cancer and melanoma patients undergoing surgery.
And the Ohio company has made a bit of history in the process. The FDA doesn't always promote every approval it grants, but it did this time, noting in its announcement that Lymphoseek "is the first new drug used for lymph node mapping to be approved in more than 30 years."
Plans call for selling Lymphoseek exclusively through Cardinal Health, with lymphatic mapping healthcare clinicians being the primary market target. Separately, the company is looking for a partner to sell the imaging agent overseas. But in both cases, Navidea will have a liaison to consult on the rollout and medical education.
Lymphoseek's delay wasn't due to any issues with the technology itself. FDA officials rejected the company's application in September over problems with a third-party contract manufacturer. Since then, Navidea worked with the FDA and the manufacturer to address the problems and refiled for FDA approval at the end of October.
Navidea tested its imaging agent on more than 540 people. In the company's pivotal Phase III trial involving 332 breast cancer or melanoma patients, Lymphoseek also performed well in comparison to blue dye, a rival agent used to help locate lymph nodes. The company said Lymphoseek was present in an average of 97% of resected lymph nodes confirmed to have cancer. It's designed to help map lymph nodes that are housing cancer to help in the cancer staging process.
As of December, Navidea is also actively pursuing a CE mark for Lymphoseek.
- read the company's release
- here's the FDA's announcement