Venetoclax (4) – Venclyxto®
Chronic lymphocytic leukaemia (CLL), first-line, in combination with obinutuzumab
Characteristics
| Start date | 15.04.2020 – Marketing authorisation: 09.03.2020 |
|---|---|
| Resolution | 15.10.2020 |
| INN | Venetoclax |
| Brand name | Venclyxto® |
| Pharm. company | AbbVie Deutschland GmbH & Co. KG |
| G-BA Procedure ID | D-533 |
| ATC code | L01XX52 Other antineoplastic agents (L01XX) |
| ICD-10 codes (AIS) | C91.10Chronic lymphocytic leukemia of B-cell type with failed remission, C91.11Chronic lymphocytic leukemia of B-cell type in remission |
| Alpha-ID codes (AIS) | I25521CLL (chronic lymphocytic leukemia), I31079CLL (chronic lymphocytic leukemia) in complete remission |
| DDD | 0.4 g O |
| Therapeutic area | Oncological diseases Chronic lymphocytic leukemia (CLL) |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
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Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with non-pretreated chronic lymphocytic leukaemia who are eligible for therapy with fludarabine in combination with cyclophosphamide and rituximab (FCR) | Fludarabine in combination with cyclophosphamide and rituximab (FCR) |
| b) | Adult patients with non-pretreated chronic lymphocytic leukaemia for whom therapy with FCR is not an option | Bendamustine in combination with rituximab or Chlorambucil in combination with rituximab or obinutuzumab |
| c) | Adult patients with non-pretreated chronic lymphocytic leukaemia with 17p deletion and/or TP53 mutation or for whom chemo-immunotherapy is not indicated for other reasons | Ibrutinib |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
| Reason for dividing into subpopulations (G-BA) | Gene/mutation specifics, Patient eligibility |
a) Adult patients with previously untreated chronic lymphocytic leukaemia who are eligible for treatment with fludarabine in combination with cyclophosphamide and rituximab (FCR)
- For venetoclax in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) who are eligible for treatment with fludarabine in combination with cyclophosphamide and rituximab (FCR) is an option, an additional benefit is not proven.
- The pharmaceutical manufacturer did not submit any data that would have been suitable for assessing the additional benefit compared with the appropriate comparator therapy.
b) Adult patients with previously untreated chronic lymphocytic leukaemia for whom treatment with fludarabine in combination with cyclophosphamide and rituximab (FCR) is not an option
- For venetoclax in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) for whom treatment with fludarabine in combination with cyclophosphamide and rituximab (FCR) is not an option, an additional benefit is not proven.
- A patient population defined by the pharmaceutical manufacturer may not fully cover the population of patients for whom FCR therapy is not suitable, but who could be treated with chemo-immunotherapy.
c) Adult patients with previously untreated chronic lymphocytic leukaemia with a 17p deletion and/or TP53 mutation, or for whom chemo-immunotherapy is not indicated for other reasons
- For venetoclax in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL), with a 17p deletion and/or TP53 mutation, or for whom chemo-immunotherapy is not indicated for other reasons, additional benefit is not proven.
- The pharmaceutical manufacturer did not submit any data that would have been suitable for assessing the additional benefit compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
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