FDA Approves Drug to Visualize Malignant Tissue During Surgery – Drug Information Update
FDA has approved Gleolan (aminolevulinic acid hydrochloride, ALA HCl), an optical imaging agent indicated in patients with gliomas (suspected World Health Organization grades III or IV on preoperative imaging) as an adjunct for visualization of malignant tissue during glioma surgery. Gleolan is the first fluorescing agent approved for use with gliomas.
Three prospective studies showed that ALA-induced fluorescence has high predictive value for visualization of malignant tissue as verified by histopathology of biopsied fluorescent tissue. The safety of Gleolan is supported by five clinical studies which included 527 patients with glioma who received ALA. Gleolan is associated with such risks as phototoxic reactions, hypersensitivity reactions, and interpretation errors (false negatives and false positives). An increase in the extent of resection might increase the risk of serious neurologic deficits in the short term. Adverse reactions that occurred in > 1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting. Other adverse reactions occurring in < 1% of patients in the first 6 weeks after surgery were chills, abnormal liver function test, and diarrhea. For more information, see the approval letter and the labeling at Drugs@FDA.
