The REALYSA study aims, among other things, to get a better understanding of the care provided to adult patients affected by different types of lymphoma in France, the treatments they receive and their response to these treatments. Real world data, collected outside of clinical trials, as in the REALYSA study, are not widely available in France and will be useful to all the stakeholders involved in the care of patients with lymphoma, ultimately for the benefit of patients.
Brentuximab Vedotin (Adcetris®) is a monoclonal anti-CD30 antibody combined with a cytotoxic molecule.
Several clinical studies have described the safety and efficacy profile of Brentuximab Vedotin and it was granted a marketing authorisation in several indications, including patients with Hodgkin’s lymphoma and certain subtypes of peripheral T-cell lymphoma. However, for various reasons, to meet patients needs, haematologists may use Brentuximab Vedotin in the management of lymphoma for indications that are not covered by a marketing authorisation.
Therefore, the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé, the French Agency supervising the safety of medicines and other health products) and TAKEDA (the pharmaceutical company holding the marketing authorisation for Adcetris®) have agreed on a local action plan to monitor the use of Adcetris® outside of the indications described in its marketing authorisation. Each year, TAKEDA has to provide the ANSM with data on the use of Adcetris® for the management of patients with lymphoma in routine clinical practice. In order to meet the ANSM’s requirements, TAKEDA was interested to get a descriptive report presenting the profile of the patients participating in the REALYSA study who received Adcetris® in 2021 and 2022.
TAKEDA will be provided with a descriptive report where the results will be aggregated and anonymised. The company will not receive any individual data.
To all patients participating in REALYSA, and more particularly for patients with Hodgkin’s lymphoma or T-cell lymphoma: if you wish to object to the use of your data for this analysis, you can contact your doctor at the care centre who invited you to take part in REALYSA or make a request at dpo@lysarc.org, as described in the Patient Information Leaflet you received at the beginning of your participation in the study. You can find in this document all the information on your rights regarding your personal data. The first data extraction is scheduled for February 2022 for the report on 2021 and in February 2023 for the report on 2021.