[confused_boner]

>the cancers were caused by the chemotherapy conditioning regimen for the treatment, not Lyfgenia itself.

I am certain some media group is going to conveniently leave this part out of the title of their article, and surely no one is gonna waste time reading the actual article and the rumors will take off.

[jorlow]

The article says "patients must undergo a preparatory treatment with a chemotherapy drug to remove any native stem cells that might remain in their bone marrow." It doesn't make much difference to the patient if it's the Lyfgenia itself or the chemo drug, if the chemo drug is a requirement. Right?

[skissane]

There is active research on doing gene therapy without requiring chemotherapy (or radiation) first. It has been shown to work in mice, and they may eventually get it working in humans too. It would likely require a significant modification to these gene therapies though, since one approach is to alter the method of growing the stem cells to produce a significantly higher number, and then transplant that, with the hope that the transplanted edited cells outnumber and outnumber the original unedited ones. So very likely the FDA would treat that as a new therapy requiring a new approval process.

https://med.stanford.edu/news/all-news/2019/05/radiation-fre...

There is also ongoing research into immunotherapy for killing stem cells, as an alternative to the existing methods of chemotherapy and radiation. Potentially, immunotherapy could have significantly reduced secondary cancer risk.

https://jhoonline.biomedcentral.com/articles/10.1186/s13045-...

[confused_boner]

I was thinking more that it could poison the reputation of gene therapy by causing folks to falsely associate cancer with gene therapy. And that false stigma could carry on even if one day chemo was no longer needed.

[eszed]

Fair enough, but there remains the possibility of finding an alternate, safer chemotherapy drug.

Does anyone know if changing the drug would require a new FDA approval for the entire regimen, or could the protocol be easily changed?