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) |
| DDD | 0.4 g O |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
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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