Radiopharmaceutical product supplier Pharmalucence said the U.S. Food and Drug Administration (FDA) has approved the use of its sulfur colloid injection (SCI) for localizing lymph nodes in patients with malignant melanoma.
The company said it conducted a systematic review of published scientific articles that describe the efficacy and safety of SCI in lymph node localization. Four studies were used in its meta-analysis, and a total of 249 patients were evaluated. SCI was present in at least one lymph node in 96.4% of the procedures, compared with 83.6% for blue dye, according to Pharmalucence.
SCI has been cleared for the detection of lymph nodes in breast cancer patients since July 2011.
