Zanubrutinib (5) – Brukinsa®
Follicular lymphoma, after ≥ 2 prior therapies, combination with obinutuzumab
Characteristics
| Start date | 15.12.2023 – Marketing authorisation: 15.11.2023 |
|---|---|
| Resolution | 06.06.2024 |
| Limitation date | 01.07.2029 |
| INN | Zanubrutinib |
| Brand name | Brukinsa® |
| Pharm. company |
Dossier: BeiGene Germany GmbH
New distributor: BeOne Medicines Germany GmbH |
| G-BA Procedure ID | D-1002 |
| ATC code | L01EL03 BTK inhibitors (L01EL) |
| ICD-10 codes (AIS) | C82.0Follicular lymphoma grade I, C82.1Follicular lymphoma grade II, C82.2Follicular lymphoma grade III, unspecified, C82.3Follicular lymphoma grade IIIa, C82.4Follicular lymphoma grade IIIb, C82.7, C82.9Follicular lymphoma, unspecified |
| Alpha-ID codes (AIS) | I116042Follicular lymphoma grade 1, I116043Follicular lymphoma grade 2, I116044Follicular lymphoma grade 3, I116045Follicular lymphoma grade 3a, I116046Follicular lymphoma grade 3b, I116049Other types of follicular lymphoma, I17968Follicular lymphoma |
| Therapeutic area | Oncological diseases Follicular lymphoma (FL) |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
BRUKINSA is used in combination with obinutuzumab for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| BRUKINSA is used in combination with obinutuzumab for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies | - Bendamustine – CHOP – CVP – chlorambucil – cyclophosphamide – MCP – R-FCM each followed by rituximab maintenance therapy if there is a response to induction therapy; – Bendamustine in combination with obinutuzumab followed by obinutuzumab maintenance therapy according to the approval – Lenalidomide in combination with rituximab – Rituximab monotherapy – Bendamustine in combination with obinutuzumab – [90Y]-radiolabeled lbritumomab tiuxetan – idelalisib |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (ROSEWOOD) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
Adults with refractory or relapsed follicular lymphoma of grades 1 to 3a who have received at least two previous courses of systemic therapy
- An additional benefit is not proven.
- In summary, there are no suitable data available to enable an assessment of additional benefit; therefore, additional benefit of zanubrutinib in combination with obinutuzumab in adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
- Overall assessment
- In summary, there are no suitable data available to enable an assessment of the additional benefit; therefore, the additional benefit of zanubrutinib in combination with obinutuzumab in adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies. It is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Zanubrutinib (5) | Brukinsa® | BeiGene Germany GmbH | Follicular lymphoma, after ≥ 2 prior therapies, combination with obinutuzumab | 370–840 | 100% additional benefit not proven | |
| Zanubrutinib (2) | Brukinsa® | BeiGene Germany GmbH | Chronic lymphocytic leukaemia (CLL), first-line | 3,180–3,200 | 50% Hint for minor additional benefit | |
| Zanubrutinib (3) | Brukinsa® | BeiGene Germany GmbH | Marginal zone lymphoma (MZL), after at least 1 previous therapy with anti-CD20 antibody | 590–1,760 | 100% additional benefit not proven | |
| Zanubrutinib (4) | Brukinsa® | BeiGene Germany GmbH | Chronic lymphocytic leukaemia (CLL), relapsed and/or refractory | 8,800–12,750 | 23% Indication of minor additional benefit | |
| Zanubrutinib (1) | Brukinsa® | BeiGene Germany GmbH | Waldenström's disease, first-line (chemo-immunotherapy unsuitable) or after at least 1 previous therapy | 450–1,050 | 100% additional benefit not proven |
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