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Brentuximab vedotin combination receives EC approval for the treatment of adult patients with untreated Stage III Hodgkin lymphoma
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On October 18, 2023, it was announced that brentuximab vedotin, a CD30-directed antibody-drug conjugate, in combination with doxorubicin, vinblastine and dacarbazine (AVD) received approval from the European Commission (EC) for the treatment of adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma. This follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.1
This approval is based on key findings from the randomized phase III ECHELON-1 trial (NCT01712490) comparing brentuximab vedotin plus AVD to doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). In 1,334 adult patients with previously untreated State III or IV classical Hodkin lymphoma.1 The study met its primary endpoint of modified progression-free survival as well as the secondary endpoint of overall survival (OS), demonstrating a statistically significant improvement in OS for the brentuximab vedotin plus AVD group.1 Additionally, the safety profile remained consistent with previous studies.1
- BusinessWire. European Commission approves ADCETRIS® (brentuximab vedotin) for the treatment of adult patients with previously untreated CD30+ stage III Hodgkin lymphoma in combination with AVD. https://www.businesswire.com/news/home/20231018884948/en/European-Commission-Approves-ADCETRIS%C2%AE-brentuximab-vedotin-for-the-Treatment-of-Adult-Patients-with-Previously-Untreated-CD30-Stage-III-Hodgkin-Lymphoma-in-Combination-with-AVD. Published October 18, 2023. Accessed October 19, 2023.
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