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Review
. 2019 Feb;141(3):479-486.
doi: 10.1007/s11060-019-03098-y. Epub 2019 Jan 14.

5-ALA and FDA approval for glioma surgery

Constantinos G Hadjipanayis  1   2 , Walter Stummer  3
Affiliations
Review

5-ALA and FDA approval for glioma surgery

Constantinos G Hadjipanayis et al. J Neurooncol. 2019 Feb.

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.

Keywords: 5-ALA; Brain tumors; FDA; Glioblastoma; Gliomas; High-grade gliomas; Intraoperative imaging; Optical imaging.

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Conflict of interest statement

Conflict of Interest:

Constantinos Hadjipanayis is a consultant for NXDC and Synaptive Medical Inc. He will receive royalties from NXDC. He has also received speaker fees by Carl Zeiss and Leica.

Walter Stummer has received speaker and consultant fees by Carl Zeiss, Leica, Photonamic, Medac, and NXDC

Figures

Figure 1.
Figure 1.
5-ALA approval timeline.
Figure 2.
Figure 2.
Summary of clinical benefit for patients undergoing 5-ALA FGS including tumor visualization with high diagnostic accuracy (high PPV), maximal EOR, and better PFS-6.
See this image and copyright information in PMC

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