Ibrutinib (7) – Imbruvica®
Waldenström's disease, combination with rituximab
Characteristics
| Start date | 01.09.2019 – Marketing authorisation: 02.08.2019 |
|---|---|
| Resolution | 20.02.2020 |
| INN | Ibrutinib |
| Brand name | Imbruvica® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-489 |
| ATC code | L01EL01 BTK inhibitors (L01EL) |
| ICD-10 codes (AIS) | C88.00, C88.01 |
| Alpha-ID codes (AIS) | I30532Waldenström´s disease, I31046Waldenström´s disease in complete remission |
| DDD | 0.49 g O |
| Therapeutic area | Oncological diseases Chronic lymphocytic leukemia (CLL), Non-Hodgkin lymphoma (NHL) Orphan (turnover limit) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling ACT change |
| Therapeutic indication of the resolution |
|---|
|
IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with Waldenström's disease | Patient-specific therapy taking into account the general condition and, if applicable, previous therapies. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (iNNOVATE) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 01.02.2019 – Zulassungsänderung Ofatumumab |
- Clinical trials
- This was a randomised, controlled trial comparing ibrutinib in combination with rituximab (arm A) against placebo and rituximab (arm B).
Adult patients with Waldenström’s macroglobulinaemia
- For ibrutinib in combination with rituximab for the treatment of adult patients with Waldenström’s macroglobulinaemia, an additional benefit over the appropriate comparator therapy is not proven.
- Overall, there are no suitable data available for the assessment of ibrutinib in combination with rituximab for the treatment of adult patients with Waldenström’s macroglobulinaemia compared with the appropriate comparator therapy.
- In particular, the pharmaceutical manufacturer was unable to provide evidence that rituximab monotherapy constitutes an adequate, patient-specific treatment for all or specific patients included in the study.
- An additional benefit of ibrutinib in combination with rituximab is not proven.
- Conclusion
- Overall, there are therefore no suitable data available to enable an assessment of the additional benefit of ibrutinib in combination with rituximab compared with the appropriate comparator therapy.
- An additional benefit of ibrutinib in combination with rituximab is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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