Ibrutinib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Chronic lymphocytic leukaemia6 | |||
None | + obinutuzumab | 1L | None |
None | + rituximab | 1L | None |
None | + venetoclax | 1L | None |
None | Monotherapy | 1L | None |
None | + bendamustine and rituximab (BR) | 2L | After at least one prior therapy |
None | Monotherapy | 2L | After at least one prior therapy |
| Mantle cell lymphoma2 | |||
None | + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without IMBRUVICA, followed by IMBRUVICA monotherapy | 1L | Eligible for autologous stem cell transplantation (ASCT) |
None | Monotherapy | 2L | None |
| Waldenström macroglobulinaemia3 | |||
None | Monotherapy | 1L | Unsuitable for chemo-immunotherapy |
None | Monotherapy | 2L | After at least one prior therapy |
None | + rituximab | Any line | None |
Full text of section 4.1 (therapeutic indications)
IMBRUVICA in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without IMBRUVICA, followed by IMBRUVICA monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT). IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL. IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1). IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy. IMBRUVICA as a single agent 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. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.
Label history
50 changes to the Imbruvica label since 2015, 8 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes