Zanubrutinib (1) – Brukinsa®

• Clinical trials
  • To demonstrate additional benefit, the pharmaceutical manufacturer has included the results of the ongoing, open-label Phase III ASPEN trial in the dossier.

Adults with Waldenström’s macroglobulinaemia who have received at least one prior course of treatment, or adults without prior treatment who are not suitable for chemoimmunotherapy

• Consequently, it is concluded that the additional benefit is not proven in accordance with Chapter 5, Section 18(1), fourth sentence of the VerfO.
• The presentation of the study data in the dossier proved to have a seriously inadequate and incomplete extent in terms of content, with the result that this precludes a proper assessment of the additional benefit.
• The dossier did not contain complete analyses of the patient-reported endpoints collected in the study for either of the two available data sets.
• Furthermore, complete subgroup analyses were missing and there were shortcomings in the analysis of the patient-reported endpoints submitted.
• 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.

Courtesy translation only, please refer to the German original.