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FDA Approves Gleolan for Use During Glioma Surgery
IDT Biologika news release; 2017 Jun 6
The FDA has approved Gleolan (aminolevulinic acid hydrochloride, ALA HCl) for use to enhance the visualization of malignant tissue during glioma surgery.
Indications: Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.
Dosage and Administration: Recommended reconstituted oral dose is 20 mg/kg. Administer orally 3 hours (range 2 to 4 hours) before anesthesia.
Efficacy and safety: Approval is based on data that show that glioblastoma patients currently survive an estimated 16 months after diagnosis. Median survival after recurrence is 7 to 9 months.
Side effects/risks: Adverse reactions in the week following surgery were pyrexia, hypotension, nausea, and vomiting.
Aminolevulinic acid hydrochloride, known as ALA HCl as an optical imaging agent indicated in patients with gliomas. [news release]. Silver Spring, MD: FDA. June 6, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm562645.htm. Accessed June 16, 2017.
Gleolan [package insert]. Dessau-Rosslau, Germany: IDT Biologika GmbH. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208630s000lbl.pdf. Accessed June 16, 2017.