Health & Medicine
FDA Approves Navidea’s Lymphoseek for Breast Cancer, Melanoma Patients
SWR Staff Writer
First Posted: Mar 14, 2013 01:00 PM EDT
The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals Inc., Lymphoseek which is a radioactive imaging agent that checks if breast cancer or melanoma has spread to lymph nodes of a patient, the organization said in a statement released Thursday.
The drug is helpful in locating lymph nodes in patients with breast cancer and skin cancer. It is the first drug for lymph node mapping to be approved in more than 30 years, the FDA noted. Other products used for lymph node mapping include sulfur colloid (approved by the FDA in 1974) and isosulfan blue (approved in 1981).
"Removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation for some patients with breast cancer or melanoma," Dr. Shaw Chen, deputy director of the Office of Drug Evaluation IV in the FDA's Center for Drug Evaluation and Research, said in a statement.
"To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek's radioactivity."
The FDA based the approval on two studies that involved 332 patients suffering from breast cancer or melanoma. The organization said the drug is slightly more efficient than previous drugs in locating the lymph nodes. The drug was earlier declined by FDA in September due to some manufacturer issues. The most common adverse effect identified in clinical trials was pain or irritation at the injection site, the FDA noted.
Meanwhile, Navidea said it has additional imaging agents in the pipeline, including a candidate in mid-stage development for diagnosing Alzheimer's disease and an additional compound for Parkinson's diagnosis.
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First Posted: Mar 14, 2013 01:00 PM EDT
The US Food and Drug Administration (FDA) has approved Navidea Biopharmaceuticals Inc., Lymphoseek which is a radioactive imaging agent that checks if breast cancer or melanoma has spread to lymph nodes of a patient, the organization said in a statement released Thursday.
The drug is helpful in locating lymph nodes in patients with breast cancer and skin cancer. It is the first drug for lymph node mapping to be approved in more than 30 years, the FDA noted. Other products used for lymph node mapping include sulfur colloid (approved by the FDA in 1974) and isosulfan blue (approved in 1981).
"Removal and pathological examination of lymph nodes draining a primary tumor is an important diagnostic evaluation for some patients with breast cancer or melanoma," Dr. Shaw Chen, deputy director of the Office of Drug Evaluation IV in the FDA's Center for Drug Evaluation and Research, said in a statement.
"To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek's radioactivity."
The FDA based the approval on two studies that involved 332 patients suffering from breast cancer or melanoma. The organization said the drug is slightly more efficient than previous drugs in locating the lymph nodes. The drug was earlier declined by FDA in September due to some manufacturer issues. The most common adverse effect identified in clinical trials was pain or irritation at the injection site, the FDA noted.
Meanwhile, Navidea said it has additional imaging agents in the pipeline, including a candidate in mid-stage development for diagnosing Alzheimer's disease and an additional compound for Parkinson's diagnosis.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone