September 1, 2019

Two anti-CD19 CAR T cell therapies are currently approved by the FDA to treat hematologic malignancies: Kymriah and Yescarta. Both therapies have the same mechanism of action and treat relapsed/refractory B-cell malignancies such as acute lymphoblastic leukemia (ALL) and large B-cell lymphoma (LBCL). Click to zoom in.

Anti-CD19 CAR T Race to Market

The infographic below shows the path to market from pre-IND for these two FDA-approved anti-CD19 CAR T cell therapies. Zoom in or click the full screen button to see the details.

Selected takeaways

• 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.

We welcome any questions or requests at bioheights@pm.me. If you would like to get a downloadable and editable version of the infographic, you can get it here, both in PDF and PowerPoint formats.

To find more interesting articles visit our Insights page.

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.