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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.
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This content is accurate as of the date of publication and is not updated retrospectively. Please refer to the latest available evidence, guidelines, and relevant regulatory information when making clinical decisions.
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