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news.Pharmalucence has gained the US Food and Drug Administration (FDA) approval for its Sulfur Colloid Injection (SCI) to locate lymph nodes in breast cancer patients.
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The lymph nodes are located using a radioactive signal with a hand-held radioactive tracer and are surgically removed and analyzed to determine if tumor cells are present.
Clinical studies reveal that patients who show no evidence of lymph node involvement may be candidates for less extensive surgical treatment than patients whose lymph nodes are positive for the presence of tumor.
Pharmalucence studied 43 publications that reported use of both SCI and a blue dye in breast cancer patients having lymph node localization.
The study of 9,213 evaluated procedures showed that SCI was present in at least one lymph node in 94.1% of procedures compared to blue dye being present in at least one lymph node in 85.1% of procedures.
The study determined that SCI is superior to blue dye when used alone, and in addition, SCI in conjunction with blue dye is also shown to be superior to blue dye alone.
Pharmalucence president and CEO Glenn Alto said as follow up, Pharmalucence will soon submit another filing that supports use of SCI in lymph node localization in melanoma patients.