Authors' recommendations: Currently, ofatumumab is approved for two indications for chronic lymphocytic leukaemia (CLL) in Europe and the US (1st line treatment & refractory CLL). Recently (January 2016), the FDA approved ofatumumab for maintenance treatment of adult patients with relapsed CLL in partial or complete remission after at least two previous treatments. The FDA approval was based on the results of the PROLONG trial, a randomised, open-label phase III study. Although the study shows a significant improvement in PFS, the lack of OS gain should be further investigated. The potential risk of the development of resistance as well as the high number of AEs should be taken into account. Therefore, long-term data will be required. More data will also be required to identify the clinical benefit for patients of specific cytogenetic subgroups.

Project Status: Completed

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

Year Published: 2016

URL for published report: http://eprints.hta.lbg.ac.at/1085/1/DSD_HSO_Nr.57.pdf

URL for additional information: http://eprints.hta.lbg.ac.at/1085/

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)