FDA gave chimeric antigen receptor (CAR) T-Cell therapy 'breakthrough designation' in 2014 - the Route to Genetic Engineering
What followed was the greatest crime against humanity in the history of the World - Let them prove me wrong!
Going to keep this short, but not sweet
There is no way to sweeten this bitter pill I am going to unveil for you here. The subtitle of this post opens the analysis:
“What followed was the greatest crime against humanity in the history of the World - Let them prove me wrong!”
It begins with chimeric antigen receptor (CAR) T-Cell therapy (CAR-T). In 2014, FDA assigned CAR-T therapy 'breakthrough designation - drugs that have been granted breakthrough status are given priority review.
The first CAR -T therapy was approved by FDA just 3 years later, in 2017. Not quite working at the “speed of science,” but not far off. The brand name of the product was Kymriah, marketed by the Swiss giant Novartis. It was reported in Fierce Pharma:
Novartis, still struggling with Kymriah manufacturing, is providing some out-of-spec doses to patients who ask
“Novartis released some new data on CAR-T drug Kymriah this month that it hopes will improve the uptake of the drug. But Novartis also continues to wrestle …