Obinutuzumab (6) – Gazyvaro®

• Clinical trials
  • To demonstrate additional benefit, the pharmaceutical manufacturer has presented the results of the randomised, controlled, open-label, multicentre Phase III GALLIUM trial in the dossier.

Patients with previously untreated advanced follicular lymphoma (FL)

• The additional benefit is not proven.
• The conclusion is therefore that additional benefit is not proven.
• The presentation of the study data in the dossier proved, in each instance, to be of serious extent inadequate and incomplete in terms of content, with the result that this precludes a proper assessment of the additional benefit.
• The dossier did not contain analyses for all the endpoints recorded for any of the data sets, particularly not for the most recent one.
• Furthermore, the analyses of health-related quality of life were inadequate.
• Moreover, the results presented on common adverse events were incomplete.
• Even the analyses submitted subsequently with the written statement were not suitable for enabling a proper assessment of the additional benefit due to their inadequate processing.
• Overall assessment
  • Consequently, the G-BA has determined, in accordance with Chapter 5, Section 18, sentence 4 of the G-BA’s Rules of Procedure (VerfO), that additional benefit is not proven.

Courtesy translation only, please refer to the German original.