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 lym 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 lym Hub cannot guarantee the accuracy of translated content. The lym 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.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View lymphoma & CLL content recommended for you
EMA's CHMP adopts a positive opinion for Adcetris® (brentuximab vedotin) for CD30+ cutaneous T-cell lymphoma (CTCL)
On 9th November 2017, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding a change to the marketing authorization for Adcetris® (brentuximab vedotin).
The CHMP has recommended that a new indication is adopted for Adcetris® for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. This decision is pending approval from the European Commission.
The recommendation was based on data from the ALCANZA phase III, randomized, open-label, multicenter clinical trial previously reported by Lymphoma Hub on 12th July 2017. The results showed brentuximab vedotin to significantly improve patient objective response rate lasting 4 months or more and complete responses, as well as improving PFS. In a video interview with Lymphoma Hub, Professor Miles Prince, an author of the published study, said the results "showed a substantial difference between the comparator arms and brentuximab vedotin" with "over a 50% difference".
Full information regarding this post-authorization summary of opinion can be found here.