Zanubrutinib (3) – Brukinsa®

Marginal zone lymphoma (MZL), after at least 1 previous therapy with anti-CD20 antibody

Characteristics

Start date 15.12.2022 – Marketing authorisation: 28.10.2022
Resolution 15.06.2023
INN Zanubrutinib
Brand name Brukinsa®
Pharm. company Dossier: BeiGene Germany GmbH
New distributor: BeOne Medicines Germany GmbH
G-BA Procedure ID D-896
ATC code L01EL03 BTK inhibitors (L01EL)
ICD-10 codes (AIS) C83.0Small cell B-cell lymphoma, C88.40
Alpha-ID codes (AIS) I116053Nodal marginal zone lymphoma, I116054Splenic marginal zone lymphoma, I116100Extranodal marginal zone B-cell lymphoma of the mucosa-associated lymphoid tissue (MALT lymphoma), I127461Nodal marginal zone B-cell lymphoma, I127462Primary cutaneous marginal zone B-cell lymphoma
DDD 0.32 g O
Therapeutic area Oncological diseases Marginal zone lymphoma (MZL)
Reason for procedure New therapeutic indication
Specialty Bundling

Therapeutic indication of the resolution

Brukinsa monotherapy is used to treat adult patients with marginal zone lymphoma (MZL) who have received at least one prior therapy with an anti-CD20 antibody.
Subpopulation Indication Comparator
Adults with marginal zone lymphoma who have received at least one prior therapy with an anti-CD20 antibody - Bendamustine – CHOP (cyclophosphamide + doxorubicin + vincristine + prednisone) – CVP (cyclophosphamide + vincristine + prednisone) – FCM (fludarabine + cyclophosphamide + mitoxantrone) + rituximab (for people with resistance to CHOP) – chlorambucil – cyclophosphamide

Studies and Results

No. of studies
(best subpopulation) 		1 (MAGNOLIA)
Study design
(best subpopulation) 		Single-arm + no comparison
Meta analysis
(best subpopulation) 		no

  • Clinical trials
    • The MAGNOLIA trial investigated the efficacy and safety of zanubrutinib in adults with marginal zone lymphoma who had received at least one prior treatment, including at least one CD20-targeted therapy.
    • The uncontrolled Phase I/II clinical study BGB-3111-AU-003 investigated zanubrutinib in patients with B-cell neoplasms.

Adults with marginal zone lymphoma who have received at least one prior course of treatment with an anti-CD20 antibody

  • The additional benefit is not proven.
  • The results of the single-arm studies MAGNOLIA and BGB-3111-AU-003 are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy; consequently, an additional benefit of zanubrutinib is not proven in adults with marginal zone lymphoma who have received at least one prior course of treatment with an anti-CD20 antibody.
  • Overall assessment
    • Results from the single-arm studies MAGNOLIA and BGB-3111-AU-003 are available for the assessment of the additional benefit of zanubrutinib in adults with marginal zone lymphoma who have received at least one prior course of treatment with an anti-CD20 antibody.
    • The results of the single-arm studies MAGNOLIA and BGB-3111-AU-003 submitted are not suitable for assessing additional benefit, as they do not allow for a comparison with the appropriate comparator therapy; consequently, the additional benefit of zanubrutinib in adults with marginal zone lymphoma who have received at least one prior course of treatment with an anti-CD20 antibody is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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