View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
April 4, 2022

Kite’s CAR T-cell therapy obtains FDA approval for large B-cell lymphoma

The approval for Yescarta is based on data from Phase III ZUMA-7 clinical trial in 359 adult patients with r/r LBCL.

Gilead Sciences’ subsidiary Kite has secured approval from the US Food and Drug Administration (FDA) for Yescarta (axicabtagene ciloleucel) CAR T-cell therapy to treat adult individuals with large B-cell lymphoma (LBCL).

Yescarta is a genetically modified autologous T cell immunotherapy directed at CD19.

The treatment is indicated for use in patients who are refractory to first-line chemoimmunotherapy or have relapsed within a year of first-line chemoimmunotherapy. 

The latest approval for the cell therapy is based on data from a randomised, multicentre, open-label, international Phase III ZUMA-7 clinical trial. 

It analysed the safety and efficacy of Yescarta against the existing standard of care (SOC) of second-line therapy in adults with relapsed or refractory (r/r) LBCL within a year of first-line treatment.

Carried out at 77 sites globally, the trial enrolled 359 subjects and randomised them into a 1:1 ratio to give a single infusion of Yescarta or SOC.

Event-free survival (EFS) was the primary endpoint of the trial while objective response rate (ORR) and overall survival (OS) were included as key secondary endpoints.

Findings showed that Yescarta offered a 2.5-fold rise in subjects alive at two years and did not have disease progression or need further treatment versus SOC.

The cell therapy also provided a four-fold improvement in median EFS.  

Furthermore, subjects in the Yescarta arm had an ORR of 83% versus 50% in the SOC arm.

Yescarta failed to demonstrate statistical significance on OS in an interim assessment while it was found to have a safety profile in line with prior trials.

Kite CEO Christi Shaw said: “Kite started with a very bold goal: creating the hope of survival through cell therapy. 

“The FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey.”

In 2018, the National Health Service (NHS) England entered an agreement with Gilead to supply Yescarta for adults with large cell lymphoma.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

Free Whitepaper

Secure the cell therapy supply chain from bench to bedside

The development of cell therapies is changing healthcare, delivering new hope to thousands of patients around the world. The vein-to-vein workflow for these therapies, however, is not without challenges, many of which will increase as we scale up to treat more patients. Download this free guide from Cytiva to learn more about the challenges and risks associated with the cryogenic supply chain for cell therapies, and how supply chain disruptions can best be mitigated.
by Cytiva Thematic

By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy

By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy