BETHESDA, MD 14 March 2013—FDA and Navidea Biopharmaceuticals Inc. on Wednesday announced the approval of technetium Tc 99m tilmanocept injection, or Lymphoseek, as an aid in identifying the first lymph node that drains the primary tumor site in patients with breast cancer or melanoma.
The radiopharmaceutical, according to FDA, is the first new drug the agency has approved for use in lymphatic mapping since 1981, when isosulfan blue became available.
Examination of the lymph nodes that drain a tumor may be helpful in determining whether a cancer has spread to a site distant from the primary site, FDA said. Lymphatic mapping helps physicians find those lymph nodes so they can be removed and examined for cancer cells.
According to the radiopharmaceutical's labeling (PDF), two Phase III studies of technetium Tc 99m tilmanocept and blue dye were conducted in patients with breast cancer or melanoma. A total of 685 lymph nodes were removed. The radiopharmaceutical was found on average in 97% of the lymph nodes. The blue dye was present on average in 59–70% of the lymph nodes.
Pain and irritation at the injection site were the most frequently reported adverse reactions during studies of the radiopharmaceutical. The labeling reports that these reactions occurred in less than 1% of the patients.
There are no contraindications to the use of technetium Tc 99m tilmanocept. However, the labeling warns clinicians that tilmanocept is chemically similar to dextran and thus the radiopharmaceutical may pose a risk of hypersensitivity reactions.
Lymphoseek will be supplied as a nonradioactive kit containing five vials of tilmanocept powder 250 mcg, five vials of diluent, prescribing information, five labels for radiation shields, and 25 labels for vials and syringes.
The labeling provides step-by-step instructions for reconstituting the powder and radiolabeling it with technetium Tc 99m pertechnetate sodium injection from a technetium Tc 99m generator. Once the diluent has been added to the vial of tilmanocept, the contents should be used within six hours.
Navidea said only Cardinal Health's radiopharmaceutical network will distribute and sell the kit.
During a conference call for investors, Navidea's chief executive officer announced that the company expects to formally launch Lymphoseek in the second quarter of 2013.