The infographic below shows the path to market from pre-IND for these two FDA-approved anti-CD19CAR T cell therapies. Zoom in or click the full screen button to see the details.
The race was indeed tight. The leader switched multiple times during the clinical development and regulatory review process.
It is critical to have smooth commercial manufacturing of autologous cell therapy product. It’s even more important when competing with other investigational products recruiting the same patient population.
Kymriah might have been approved for the treatment of r/r DLBCL much earlier. However, the FDA pushed back the cut-off date for efficacy/safety data by 6 months. With now FDA-approved anti-CD19 CAR T, Novartis had to elaborate on Kymriah’s advantages over Yescarta in the BLA submission. In contrast, Yescarta’s regulatory package discusses only sub-optimal chemotherapy regimens.
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Disclaimer: All information on the infographic is in the public domain. Sources include the FDA public documents, press releases, clinical trials, etc. BioHeights LLC and its members have never had and do not currently have any confidential information related to these products.