Authors' recommendations: Currently, obinutuzumab is approved as combination therapy with chlorambucil for the treatment of patients with untreated chronic lymphocytic leukaemia (CLL) both in Europe and the US. Recently (February 2016), the US Food and Drug Administration (FDA) approved obinutuzumab for the treatment of patients with follicular lymphoma (FL), who did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen; also the European Medicines Agency (EMA) adopted a positive opinion for this indication. The FDA approval was based on the results of a phase III study, GADOLIN, which is available in abstract form only. Although the study shows a significant improvement in PFS, the lack of mature OS data, in addition to the fact that there was no difference in overall response (OR) highlights the need for long-term data. Furthermore, a long-term safety profile as well as further quality of life (QoL) data will be necessary to exclude any risks of late side effects. In addition, any original article presenting the study will need to identify potential advantages and disadvantages for specific subgroups.

Project Status: Completed

URL for project: http://eprints.hta.lbg.ac.at/1100/

Year Published: 2016

URL for published report: http://eprints.hta.lbg.ac.at/1100/1/DSD_HSO_Nr.60.pdf

URL for additional information: http://hta.lbg.ac.at/page/horizon-scanning-in-der-onkologie/en

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Austria

Organisation Name: Ludwig Boltzmann Institute for Health Technology Assessment

Contact Address: Ludwig Boltzmann Institute for fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7/rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99

Contact Name: tarquin.mittermayr@aihta.at

Contact Email: office@aihta.at

Copyright: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)