Earlier this year, Yescarta® became the first CAR T-cell therapy approved by the U.S. Food and Drug Administration for treating blood cancers after only one other treatment has failed.
The next step is approving the cancer cell and gene therapy for use right after a patient is diagnosed.
Results from the ZUMA-12 clinical trial give hope that patients with large B-cell lymphoma may receive access to the Yescarta CAR T-cell treatment as soon as possible. The study enrolled 42 patients with large B-cell lymphoma, the most common type of non-Hodgkin lymphoma (NHL).
The one-year survival rate for Yescarta as a first-line therapy was 91%, which is comparable to chemotherapy. The overall response rate was 89%. Overall response rate is the percentage of people whose tumor stopped growing thanks to the CAR T-cell therapy.
“Complete response” means the tumor shrank so much that the disease doesn’t show up on imaging scans. The complete response rate was 78%.
Explaining when lymphoma patients can start CAR T-cell treatment
Currently, Yescarta is approved as a “second-line therapy,” which means NHL patients must try another treatment first before qualifying for CAR T-cell therapy. The first treatment available to patients with large B-cell lymphoma is chemotherapy.
Two other CAR T-cell therapies – Kymriah and Breyanzi – are approved for NHL but they each require at least two attempts with other treatments.
Both are attempting to get approval for earlier use. As of now, though, Yescarta offers non-Hodgkin lymphoma patients the quickest route to CAR T-cell therapy.
Timeline of FDA approvals for Yescarta
The original FDA approval of Yescarta, the brand name of axicabtagene ciloleucel, was as a third-line therapy. The agency issued this approval in October of 2017. Patients had to try chemotherapy and a stem-cell transplant before they could move onto the CAR T-cell therapy.
The FDA updated the approval in April of 2022 to make Yescarta available in the second line of treatment. This is the first and only CAR T-cell therapy approved as a second-line option. The other five approved CAR T-cell therapies are authorized for various types of blood cancer and all require at least two rounds of therapy before they’re options for patients.
- With Approval for Axi-cel in Second-line on the Horizon, CAR T-Cell Therapy Poised to Enter New Phase. American Journal of Managed Care. Retrieved from: https://www.ajmc.com/view/with-approval-for-axi-cel-in-second-line-on-the-horizon-car-t-cell-therapy-poised-to-enter-new-phase. Accessed: 02/16/2022.