Brentuximab Vedotin (Adcetris®) is a monoclonal anti-CD30 antibody combined with a cytotoxic molecule.
The efficacy of this drug has been proven in several clinical studies, and marketing approval has been granted in several indications, including for patients with Hodgkin lymphoma or for certain subtypes of peripheral T lymphoma. For many reasons, hematologists currently use Brentuximab Vedotin in contexts of patient management somewhat different from the initial indications listed in the marketing authorization.
As a result, ANSM (National Agency for the Safety of Medicines and Health Products) and TAKEDA (market authorization holder) have validated a local action plan to regulate the non-compliant use of Adcetris®. Each year, TAKEDA provides ANSM with data on how Adcetris® is used in routine clinical practice for the management of lymphoma patients. In order to respond to ANSM’s request, TAKEDA asked a descriptive report presenting the profile of patients included in REALYSA who had been treated with Adcetris® in 2019 and 2020.