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

Introducing

Now you can personalise
your Lymphoma Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

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

The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene and Roche, and supported through educational grants from Bristol Myers Squibb, Ipsen Biopharmaceuticals, Lilly, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC View funders.

2020-05-20T11:17:46.000Z

Brentuximab vedotin plus CHP is approved by the European Commission and China for the treatment of adult patients with sALCL

May 20, 2020
Share:

Bookmark this article

On May 14, 2020, brentuximab vedotin in combination with cyclophosphamide, doxorubicin, prednisone (CHP) was granted an extension on the current conditional marketing authorization by the European Commission for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL). Brentuximab vedotin has previously received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.1

The European Commission approval was based on positive data from ECHELON-2 phase III trial (NCT01777152). The trial evaluated brentuximab vedotin plus CHP vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as first-line treatment in patients with CD30+ peripheral T-cell lymphoma, which included the sALCL subtype. The ECHELON-2 trial met its primary endpoint and demonstrated a statistically significant improvement in progression-free survival with brentuximab vedotin plus CHP (HR, 0.71; p = 0.0110).1

The safety profile from the ECHELON-2 study was comparable between the two treatment arms and consistent with the established safety profile of brentuximab vedotin combined with chemotherapy.1

China

Brentuximab vedotin has also been granted fast-track approval by China’s National Medical Products Administration for the treatment of adult patients with relapsed or refractory sALCL or CD30+ Hodgkin lymphoma. The approval was also based on the results from the ECHELON-2 trial.2

  1. Pipeline Review. European Commission approves ADCETRIS® (brentuximab vedotin) for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma. https://pipelinereview.com/index.php/2020051474636/Antibodies/European-Commission-Approves-ADCETRIS-brentuximab-vedotin-for-Treatment-of-Adult-Patients-with-Previously-Untreated-Systemic-Anaplastic-Large-Cell-Lymphoma.html. Published May 14, 2020. Accessed May 18, 2020.
  2. Pharmaceutical Technology. Takeda receives China approval for Adcetris to treat lymphoma. https://www.pharmaceutical-technology.com/news/takeda-adcetris-china-ec-approval/. Published May 15, 2020. Accessed May 18, 2020.

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

HCPs, what is your preferred format for educational content on the Lymphoma Hub?
42 votes - 79 days left ...

Newsletter

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