as posted previously.... | BNGO Message Board Posts


Bionano Genomics, Inc.

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Msg  1314 of 1470  at  11/29/2023 10:27:07 AM  by

JoeFlow


 In response to msg 1313 by  JoeFlow
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Re: as posted previously....

 also recent news from FDA posted on biotech mb will be even more of a driver for OGM than CRISPR approaches.  I'll try to comment on this later in more detail.
 
All CAR-T therapies use lentivirus/retrovirus vectors for genetic engineering.  retroviruses such as HIV are RNA viruses that make a reverse transcriptase to create a DNA copy of their genome, which is inserted into the host genome.  This process can disrupt and/or mutate the function of normal/healthy genes leading to malignancies now being seen in some patients.
 
Thanks to lady minx for posting this on biotech mb.
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FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class. Currently approved products in this class (listed alphabetically by trade name) include the following:

  • Abecma (idecabtagene vicleucel)
  • Breyanzi (lisocabtagene maraleucel)
  • Carvykti (ciltacabtagene autoleucel)
  • Kymriah (tisagenlecleucel)
  • Tecartus (brexucabtagene autoleucel)
  • Yescarta (axicabtagene ciloleucel)

Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action.

 


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