Zanubrutinib (Brukinsa®) – Waldenström's disease, first-line (chemo-immunotherapy unsuitable) or after at least 1 previous therapy
Characteristics
| Start date | 15.12.2021 |
|---|---|
| Resolution | 16.06.2022 |
| INN | Zanubrutinib |
| Brand name | Brukinsa® |
| Pharm. company |
Dossier: BeiGene Germany GmbH
New distributor: BeiGene Netherlands B.V. |
| G-BA procedure ID | 2021-12-15-D-761 |
| ATC code | L01EL03 |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
| Indication (German) |
|---|
|
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. |
9. Associated procedures
| Resolution | INN | Brand name | Indication | Patients | Additional benefit |
|---|---|---|---|---|---|
| 15.12.2021 – 16.06.2022 | Zanubrutinib | Brukinsa® | Waldenström's disease, first-line (chemo-immunotherapy unsuitable) or after at least 1 previous therapy | 450 – 1,050 |
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