Ibrutinib

Ibrutinib (Imbruvica, Janssen-Cilag International NV) has 11 EU-approved indications in 3 tumour types.
Approved indications of Ibrutinib
Biomarker requirementRegimenSettingConditions
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