FDA Investigates Car T Immunotherapies

[Commsman]

https://www.fda.gov/vaccines-blood-biol ... autologous

JNJ dropped the CD with Geron largely because they believed Car-T was the future of cancer treatments. This is a sad turn of events for cancer patients, but probably a good thing for Geron investors.

"The Food and Drug Administration (FDA) has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event (AE) data sources.

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)

[Commsman]

This just came out today, Nov 28, 2023.

[kmall]

Abecma - Bristol Meyers Squibb (Celgene)
Breyanzi - Bristol Meyers Squibb
Carvykti - JNJ (Janssen)
Kymriah - Novartis
Tecartus - Gilead (Kite Pharma)
Yescarta - Gilead (Kite Pharma)

https://www.fiercepharma.com/pharma/fda ... -treatment

Wow!!!

Some fairly big M&A deals in pharma these past few years - two of the largest on the back of CAR-t.....

(2017) - Gilead buys Kite Pharma for $11.9B

https://www.gilead.com/news-and-press/p ... 19-billion


(2019) - Bristol Meyers buys Celgene for $74B

https://www.biospace.com/article/done-b ... on-merger/


.....what would Homer say? -Kmall


https://youtu.be/YkLUho5wLLY?si=a-IwnWXDZ1sXlpsa

[Commsman]

DOH!