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01-02-2019 | Glioblastoma | Topic Review

5-ALA and FDA approval for glioma surgery

Authors: Constantinos G. Hadjipanayis, Walter Stummer

Published in: Journal of Neuro-Oncology | Issue 3/2019

Abstract

The US Food and Drug Administration (FDA) approved 5-aminolevulinic acid (5-ALA; Gleolan^®; photonamic GmbH and Co. KG) for use as an intraoperative optical imaging agent in patients with suspected high-grade gliomas (HGGs) in 2017. This was the first ever optical imaging agent approved as an adjunct for the visualization of malignant tissue during surgery for brain tumors. The approval occurred a decade after European approval and a multicenter, phase III randomized trial which confirmed that surgeons using 5-ALA fluorescence-guided surgery as a surgical adjunct could achieve more complete resections of tumors in HGG patients and better patient outcomes than with conventional microsurgery. Much of the delay in the US FDA approval of 5-ALA stemmed from its conceptualization as a therapeutic and not as an intraoperative imaging tool. We chronicle the challenges encountered during the US FDA approval process to highlight a new standard for approval of intraoperative optical imaging agents in brain tumors.

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Title: 5-ALA and FDA approval for glioma surgery
Authors: Constantinos G. Hadjipanayis
Walter Stummer
Publication date: 01-02-2019
Publisher: Springer US
Keywords: Glioblastoma
Glioma
Glioma
Glioblastoma
Brain Tumor
Glioblastoma
Glioma
Published in: Journal of Neuro-Oncology / Issue 3/2019
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI: https://doi.org/10.1007/s11060-019-03098-y

ACC 2024 Congress

Springer Medicine

5-ALA and FDA approval for glioma surgery

Abstract

ACC 2024 Congress

Springer Medicine

Abstract

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