Thursday 15 June 2017

Gleolan (5-ALA fluorescence guided resection) approved by the FDA

It's about time this was approved in the US.

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm562645.htm

7 comments:

  1. My Neurosurgeon used this during resection 2 years ago and I believe it is a strong contributor to my 99% resection.

    Marc

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  2. Is it expected to improve outcomes overall?

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    Replies
    1. Yes, a more complete resection would be expected to improve survival. In the original phase 3 trial in Europe, contrast enhancing tumor was completely resected in 65% of patients in the 5-ALA arm versus 36% in the control arm. Progression-free survival at 6 months was 41% in the 5-ALA arm versus 21% in the control arm. This is why it was approved in Europe 10 YEARS ago. Finally the US catches up.

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    2. But I think I read somewhere it is more useful in GBM, not so much in LGG

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    3. Yes, I believe the intact BBB in LGG prevents it from being taken up by the tumor.

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    4. One study showed most (83%) of WHO grade 2 gliomas don't show fluorescence after 5-ALA treatment.
      https://www.ncbi.nlm.nih.gov/pubmed/26366972

      However one study proposed enhanced 5-ALA fluorescence in IDH1 mut gliomas, although this was based on genetically engineered U87 cells.
      https://www.ncbi.nlm.nih.gov/pubmed/26008980

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  3. Dr Colin Watts, a neurosurgeon from Cambridge England, discusses 5-ALA in a 2013 youtube video. The 5-ALA bit starts about 24:40.
    https://www.youtube.com/watch?v=FKRLjh1H28k

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