Spencer Knight: CGT approvals are ARRIVING, Here’s 3 BLAs to keep your eye on
Spencer Knight, Principal Business Consultant of Cell and Gene Therapy, shared on LinkedIn:
“CGT approvals are ARRIVING,
Here’s 3 BLAs to keep your eye on
1.ย ๐๐ญ๐๐ซ๐ ๐๐ข๐จย ๐ฒ๐๐ฌ๐ญ๐๐ซ๐๐๐ฒ submitted a Biological Licence Application (BLA) to the FDA for tabelecleucel, proposed as a monotherapy for treating Epstein-Barr virus positive post-transplant lymphoproliferative disease (๐๐๐+ ๐๐๐๐) in patients aged 2+ and have undergone at least one prior therapy.
For solid organ transplant patients, prior therapy includes chemotherapy unless deemed inappropriate. Notably, there are currently ๐ง๐จ ๐ ๐๐-๐๐ฉ๐ฉ๐ซ๐จ๐ฏ๐๐ ๐ญ๐ก๐๐ซ๐๐ฉ๐ข๐๐ฌ for this condition.
Autolus Therapeutics‘ submitted a BLA for obe-cel as a treatment for relapsed/refractory B-cell ALL. The submission was supported by data from the phase 1b/2 FELIX trial, results included a high complete response rate and minimal residual disease negativity. ๐๐ก๐ ๐๐๐๐ ๐ ๐๐๐ญ๐ข๐จ๐ง ๐๐๐ญ๐ is 16/11/24
PTC Therapeuticsย last week submitted a BLA for their gene therapy,ย Upstazaโขย (eladocagene exuparvovec), targeting aromatic L-amino acid decarboxylase (AADC) deficiency. The FDA accepted this application and granted it Priority Review status. ๐๐ก๐ ๐ญ๐๐ซ๐ ๐๐ญ ๐๐๐ญ๐ข๐จ๐ง ๐๐๐ญ๐ ๐ฌ๐๐ญ by 13/10/24.
๐๐ก๐๐ญ ๐๐๐ ๐ฌ๐ฎ๐๐ฆ๐ข๐ฌ๐ฌ๐ข๐จ๐ง๐ฌ ๐๐ซ๐ ๐๐๐ญ๐๐ก๐ข๐ง๐ ๐ฒ๐จ๐ฎ๐ซ ๐ข๐ง๐ญ๐๐ซ๐๐ฌ๐ญ?”
Source: Spencer Knight/LinkedIn
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