Imbruvica (ibrutinib)
- Region
- 🇪🇺 EU
- Active substance
- ibrutinib
- Company
- Janssen-Cilag International NV
- Status
- Authorised
- Therapeutic area
- Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
- CHMP opinion
- Fri 25 Jul 2014
- EU approval
- Tue 21 Oct 2014
- Application
- EMEA/H/C/003791
- ATC
- L01EL01
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.