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SMC ID Date Medicine Submission Type Indication
SMC2543 11/09/2023 ibrutinib (Imbruvica) Full

In combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
SMC2485 11/04/2022 ibrutinib (Imbruvica) Non submission

In combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
SMC2387 13/12/2021 ibrutinib (Imbruvica) Full

As a single agent 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.
SMC2259 12/10/2020 ibrutinib (Imbruvica) Full

In combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia.
SMC2244 11/11/2019 ibrutinib (Imbruvica) Non submission

In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.
SMC2245 11/11/2019 ibrutinib (Imbruvica) Non submission

As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
1289/17 13/11/2017 ibrutinib (Imbruvica) Non submission As a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (who do not have 17p deletion or TP53 mutation).
1258/17 12/06/2017 ibrutinib (Imbruvica) Non submission In combination with bendamustine and rituximab for the treatment of adult patients with chronic lymphocytic leukaemia who have received at least one prior therapy.
1151/16 10/04/2017 ibrutinib (Imbruvica) Resubmission The treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
1151/16 08/08/2016 ibrutinib (Imbruvica) CLL Full Treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
1150/16 08/08/2016 ibrutinib (Imbruvica) MCL Full Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Publication due date SMC meeting date Medicine Submission Type Indication
TBC TBC ibrutinib (Imbruvica) Full

In combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP) alternating with rituximab, dexamethasone, high-dose cytarabine and cisplatin (R-DHAP) or rituximab, dexamethasone, high-dose cytarabine and oxaliplatin [R-DHAOx]) without ibrutinib, followed by ibrutinib 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).