Zanubrutinib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Chronic lymphocytic leukaemia1 | |||
None | Monotherapy | Any line | None |
| Follicular lymphoma1 | |||
None | + obinutuzumab | 3L+ | After at least two prior systemic therapies; Relapsed or refractory |
| Marginal zone lymphoma1 | |||
None | Monotherapy | 2L | After at least one prior anti-CD20-based therapy |
| Waldenström macroglobulinaemia2 | |||
None | Monotherapy | 1L | Unsuitable for chemo-immunotherapy |
None | Monotherapy | 2L | After at least one prior therapy |
Full text of section 4.1 (therapeutic indications)
BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. BRUKINSA as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. BRUKINSA as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL). BRUKINSA in combination with obinutuzumab is indicated for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Label history
18 changes to the Brukinsa label since 2022, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes