author:"Mueller-Berghaus, Jan" | Pollux - Fachinformationsdienst Politikwissenschaft

Open Access#12016

The European Medicines Agency Review of Brentuximab Vedotin (Adcetris) for the Treatment of Adult Patients With Relapsed or Refractory CD30+ Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use

Gravanis, Iordanis; Tzogani, Kyriaki; van Hennik, Paula; de Graeff, Pieter; Schmitt, Petra; Mueller-Berghaus, Jan; Salmonson, Tomas; Gisselbrecht, Christian

Gravanis, Iordanis; Tzogani, Kyriaki; van Hennik, Paula; de Graeff, Pieter; Schmitt, Petra; Mueller-Berghaus, Jan; Salmonson, Tomas; Gisselbrecht, Christian; Laane, Edward; Bergmann, Lothar; Pignatti, Francesco

Brentuximab vedotin is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE). The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. The scientific review of the application leading to approval in the European Union is summarized in the present report.