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, Pfizer, and Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC. View funders.

2018-11-19T13:34:45.000Z

FDA grants approval to brentuximab vedotin for frontline PTCL

Nov 19, 2018
Share:

Bookmark this article

On 18 November 2018, brentuximab vedotin in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, and prednisone) was granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This approval comes after brentuximab vedotin was granted Breakthrough Therapy Designation on 16 November 2018.

The approval granted by the FDA was based on the positive results obtained from the multi-center, randomized, double-blind, placebo-controlled phase III ECHELON-2 trial (NCT01777152) assessing brentuximab vedotin in combination with CHP versus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) alone, as a frontline therapy in patients with CD30-expressing PTCL.

The phase III ECHELON-2 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) of brentuximab vedotin in combination with CHP versus CHOP as assessed by a Blinded Independent Central Review facility (BICR, HR = 0.71, 95% CI, 0.54–0.93, P = 0.011), corresponding to a 29% reduction in the risk of progression, death, or treatment of residual or progressive disease. In addition, brentuximab vedotin plus CHP led to a superior overall survival compared to standard CHOP chemotherapy (HR = 0.66, 95% CI, 0.46–0.95, P = 0.024) in the treatment of CD30-expressing PTCL. The results of the phase III ECHELON-2 study will be presented at the American Society of Hematology (ASH) 2018 Annual Meeting.

According to the drug manufacturers, the FDA, approved brentuximab vedotin via a new review program, Real-Time Oncology Review Pilot Program, which occurred less than two weeks from the date that the complete application was submitted.

  1. PipelineReview: Seattle Genetics announces FDA approval of ADCETRIS® (Brentuximab Vedotin) in combination with chemotherapy for adults with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-Cell lymphomas. 2018 Nov 18. https://pipelinereview.com/index.php/2018111869772/Antibodies/Seattle-Genetics-Announces-FDA-Approval-of-ADCETRIS-Brentuximab-Vedotin-in-Combination-with-Chemotherapy-for-Adults-with-Previously-Untreated-Systemic-Anaplastic-Large-Cell-Ly.html. [Accessed 2018 Nov 19].

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?
26 votes - 5 days left ...

Newsletter

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