View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
May 30, 2022

FDA approves Novartis’ cell therapy for follicular lymphoma in adults

The FDA approved Kymriah based on findings from the Phase II ELARA trial of the cell therapy in FL patients.

Novartis has obtained accelerated approval from the US Food and Drug Administration (FDA) for its CAR-T cell therapy Kymriah (tisagenlecleucel) to treat adults with relapsed or refractory (r/r) follicular lymphoma (FL), following two or more lines of systemic therapy.

Continued approval for the current indication may be subject to verifying and describing clinical benefits in the confirmatory trial(s) as per the Accelerated Approval Program.

Kymriah can be given in an outpatient setting, providing patients and care teams with enhanced flexibility and possibly reducing the therapeutic burden.

With the latest approval, Kymriah is currently approved for three indications and is the only CAR-T cell therapy to obtain approval in adult and paediatric settings.

The FDA approved Kymriah based on findings from the single-arm, open-label Phase II ELARA clinical trial of the cell therapy in 90 subjects.

The trial analysed the efficacy of Kymriah with a median follow-up of nearly 17 months.

Findings showed that 86% of subjects who received the Kymriah treatment attained a response while 68% of the subjects had a complete response.

For the 97 subjects who were evaluable for safety at a median follow-up of 21 months, Kymriah’s safety profile was found to be remarkable. 

In the trial, 53% of subjects had any-grade cytokine release syndrome (CRS), as defined by the Lee scale, with no cases of high-grade CRS observed. 

Novartis Innovative Medicines US president Victor Bulto said: “We are proud of the FDA approval of a third indication for Kymriah.

“We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma.”

The latest development comes after the European Commission granted approval for Kymriah to treat adults with r/r FL.

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


Thank you for subscribing to Pharmaceutical Technology