Novartis has secured priority review from the US Food and Drug Administration (FDA) for the supplemental biologics licence application (sBLA) of its Kymriah (tisagenlecleucel) to treat relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

The approval covers patients who are not eligible for or failed autologous stem cell transplant (ASCT).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Additionally, the European Medicines Agency (EMA) permitted accelerated assessment to the drug’s marketing authorisation application (MAA) for paediatric and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL), as well as adults suffering from r/r DLBCL and ineligible for ASCT.

Kymriah is a chimeric antigen receptor T-cell (CAR-T) therapy that was initially approved by the FDA in August 2017 to treat refractory B-cell precursor ALL patients aged up to 25 years.

“We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients.”

Novartis Oncology Global Drug Development head Samit Hirawat said: “The priority review designation and accelerated assessment signal that the FDA and EMA have recognised the potential of Kymriah to provide a much-needed therapeutic option for these patients with r/r B-cell ALL and DLBCL.

“We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of 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.

Both the US and European regulatory applications included findings from the firm’s global clinical trial programme conducted in r/r B-cell ALL and DLBCL patients to assess the safety and efficacy of Kymriah.

Over the coming months, the firm intends to submit additional regulatory applications for Kymriah in markets outside the US and European Union (EU).