FDA OKs Gleolan, First Fluorescing Agent for Glioma Surgery

Megan Brooks

June 08, 2017

The US Food and Drug Administration (FDA) has approved aminolevulinic acid hydrochloride (Gleolan, NX Development), the first fluorescing optical imaging agent approved for use with gliomas.

Gleolan for oral solution (1500 mg), which had orphan drug status, is indicated for use 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, the FDA says.

Three prospective studies showed that aminolevulinic acid-induced fluorescence has "high predictive value for visualization of malignant tissue as verified by histopathology of biopsied fluorescent tissue," the agency notes.

Results of five clinical studies involving 527 patients with glioma who received aminolevulinic acid support the safety of the product, they say.

Gleolan is associated with such risks as phototoxic reactions, hypersensitivity reactions, and interpretation errors (false negatives and false positives).

Phototoxic drugs (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines) and topical preparations containing aminolevulinic acid should not be administered for 24 hours during the perioperative period. Exposure to sunlight or room lights should be reduced for 24 hours after surgery, according to the label.

Adverse reactions that occurred in fewer than 1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting. Other adverse reactions occurring in fewer than 1% of patients in the first 6 weeks after surgery were chills, abnormal liver function test results, and diarrhea.

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