All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.

The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

The Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
You're logged in! Click here any time to manage your account or log out.
You're logged in! Click here any time to manage your account or log out.

Axicabtagene ciloleucel approved by the EC for the treatment of DLBCL and PMBCL

Aug 28, 2018

Bookmark this article

On 27 August 2018, the European Commission (EC) granted a marketing authorization for axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

The European Medicine's Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for axicabtagene ciloleucel (axi-cel) on 29 June 2018. It is a CD19-directed chimeric antigen receptor CAR-T therapy that was granted PRIME status (priority medicines) by the EMA in 2016. Axi-cel was approved by the US Food and Drug Administration (FDA) on October 18 2017. 

The marketing authorization means that axi-cel will be able to be prescribed as a treatment, in accordance with the indication, in countries in the European Union and Norway, Iceland and Liechtenstein. The approval follows results from the ZUMA-1 clinical study.

Professor Frederik Locke, H.Lee Moffitt Cancer Center, Tampa, Florida, commented on the duration of response from the study at the annual meeting of the American Society of Clinical Oncology in Chicago, June 2018. "What we found was that for patients in a partial response or complete response, at three months after a single infusion of CAR-T therapy, 80% of those patients remained in remission one year after the therapy was given." He added that "many of those responses deepened over time."

Understanding your specialty helps us to deliver the most relevant and engaging content.

Please spare a moment to share yours.

Please select or type your specialty

  Thank you

Your opinion matters

Which treatment do you select for patients with follicular lymphoma after multiple relapses?
0 votes - 6 days left ...


Subscribe to get the best content related to lymphoma & CLL delivered to your inbox