Zanubrutinib (1) – Brukinsa®

Waldenström's disease, first-line (chemo-immunotherapy unsuitable) or after at least 1 previous therapy

Characteristics

Start date 15.12.2021 – Marketing authorisation: 22.11.2021
Resolution 16.06.2022
INN Zanubrutinib
Brand name Brukinsa®
Pharm. company Dossier: BeiGene Germany GmbH
New distributor: BeOne Medicines Germany GmbH
G-BA Procedure ID D-761
ATC code L01EL03 BTK inhibitors (L01EL)
ICD-10 codes (AIS) C88.00, C88.01
Alpha-ID codes (AIS) I30532Waldenström´s disease, I31046Waldenström´s disease in complete remission
DDD 0.32 g O
Therapeutic area Oncological diseases Chronic lymphocytic leukemia (CLL), Non-Hodgkin lymphoma (NHL)
Reason for procedure Initial assessment

Therapeutic indication of the resolution

BRUKINSA monotherapy is used to treat adult patients with Morbus Waldenström (MW) who have received at least one prior therapy, or for first-line therapy in patients who are not suitable for chemo-immunotherapy.
Subpopulation Indication Comparator
Adults with Morbus Waldenström (MW) who have received at least one prior therapy or adults without prior therapy who are not suitable for chemoimmunotherapy A patient-specific therapy taking into account the general condition and, if applicable, previous therapies and the duration of remission after initial therapy.

Studies and Results

No. of studies
(best subpopulation) 		1 (Aspen)
Study design
(best subpopulation) 		H2H vs. ACT
Meta analysis
(best subpopulation) 		no

  • 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.

Associated procedures



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