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 | BeiGene Germany GmbH |
| G-BA Procedure ID | D-1002 |
| ATC code | L01EL03 BTK inhibitors (L01EL) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
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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