This is the pharmaceutical Joint Assessment PTJA06 – on polatuzumab vedotin for the treatment of relapsed/refractory DLBCL. In January 2020, The European Commission granted conditional marketing authorisation for Polivy® (polatuzumab vedotin), in combination with bendamustine plus MabThera® (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a haematopoietic stem cell transplant. This Joint Assessment aims to compare the clinical effectiveness and safety of polatuzumab vedotin in the target patient populations with relevant comparators according to the national requirements of EUnetHTA partners.
Below is the documentation provided by the Joint Assessment authoring team (project plan, assessment report and responses to the factual accuracy check performed by Roche) and by Roche, the Marketing Authorisation Holder of polatuzumab vedotin (PTJA06 submission dossier).
For any questions regarding the assessment, please contact WP4_Pharmaceuticals@zinl.nl
PTJA06 – Final Project Plan-V2.0
PTJA06 – Final Assessment report
PTJA06 – MAH Core Submission Dossier
PTJA06 – External Comments – Factual Accuracy Check MAH