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5-ALA and FDA approval for glioma surgery
Open accessAbstract
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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“ALA-PpIX fluorescence-guided tumor resection has been approved for high-grade gliomas and bladder cancers where it shows better surgical outcomes than conventional white light surgery.”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [43]
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“This landmark clinical trial together with additional clinical studies conducted afterward provided enough evidence for the FDA to grant the approval of ALA hydrochloride (Gleolan) in 2017 [43]. The approval allows the use of ALA as an intraoperative imaging probe to facilitate tumor resection in patients with high-grade gliomas (grade III or IV) following a standard oral administration of 20 mg/k”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [43]
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“Because ALA-mediated PpIX fluorescence in tumor tissues is able to provide surgeons with a real-time guide for tumor diagnosis and margin assessment, ALA has been used as an intraoperative probe to facilitate tumor resection [43].”
From 5-Aminolevulinic Acid as a Theranostic Agent for Tumor Fluorescence Imaging and Photodynamic Therapy (2023) · cites this paper as [43]
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Metadata
- Authors
- Hadjipanayis, C. G., & Stummer, W.
- Affiliations
- University Hospital Münster (DE)
- Venue
- Journal of Neuro-Oncology
- Published
- 2019-01-14
- Volume
- 141
- Issue
- 3
- Pages
- 479-486
- ISSN
- 0167-594X (ISSN-L)
- 1573-7373
- PMC
- PMC6445645
- OpenAlex
- W2910072132
- Cited by
- 338
- References
- 59
- Citations by year
- 2026: 19 · 2025: 53 · 2024: 60 · 2023: 51 · 2022: 59 · 2021: 52 · 2020: 32 · 2019: 12
- FWCI
- 4.75
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Journal of Neuro-Oncology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Merck
- Novocure
- Arbor Pharmaceuticals
- National Cancer Institute (R01CA176659)
- Topics
- Health Sciences › Medicine › Oncology › Glioma Diagnosis and Treatment
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Optical Imaging and Spectroscopy Techniques
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Photodynamic Therapy Research Studies
- Keywords
- 5-aminolevulinic acid, fluorescence-guided surgery, high-grade glioma, FDA drug approval, brain tumor surgery, tumor resection completeness, regulatory challenges
- MeSH terms
- Aminolevulinic Acid, Brain Neoplasms, Fluorescent Dyes, Glioma, Humans, United States, United States Food and Drug Administration, Drug Approval, Surgery, Computer-Assisted, Optical Imaging
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