Biopharmaceutical company Biogen Idec had on display details regarding its Zevalin therapeutic regimen - which reduces the number of required gamma camera studies to assess biodistribution - at the American Society for Therapeutic Radiology and Oncology (ASTRO) annual meeting in Denver, Colo., in mid-October.
The FDA recently approved a labeling supplement for the Zevalin which indicates the decrease in required scans which the company claims will simplify treatments. The decision followed a review of data from the Zevalin Imaging Registry, a collection of gamma scan images from more than 900 patients evaluated for treatment with the Zevalin therapeutic regimen. The FDA concluded that only one scan should be taken in the Zevalin therapeutic regimen 48 to 72 hours following the infusion of In-111 Zevalin.
Recently, concern has broken out over the safety of the Zevalin due to the potential of fatal side effects which prompted the FDA to later issue a warning about the drug, the Wall Street Journal recently reported.
The FDA also has required the drug labeling to be updated to disclose the possibility of fatal skin reactions in patients who are given the drug.