Axicabtagen-Ciloleucel (4) – Yescarta®
Follicular lymphoma, after ≥ 3 prior therapies
Characteristics
| Start date | 01.07.2023 – Marketing authorisation: 21.06.2022 |
|---|---|
| Resolution | 21.12.2023 |
| Limitation date | 01.07.2024 limitation repealed |
| INN | Axicabtagen-Ciloleucel |
| Brand name | Yescarta® |
| Pharm. company | Gilead Sciences GmbH |
| G-BA Procedure ID | D-889 |
| ATC code | L01XL03 OTHER ANTINEOPLASTIC AGENTS (L01X) |
| ICD-10 codes (AIS) | C82.0Follicular lymphoma grade I, C82.1Follicular lymphoma grade II, C82.2Follicular lymphoma grade III, unspecified, C82.3Follicular lymphoma grade IIIa, C82.4Follicular lymphoma grade IIIb, C82.7, C82.9Follicular lymphoma, unspecified |
| Alpha-ID codes (AIS) | I116042Follicular lymphoma grade 1, I116043Follicular lymphoma grade 2, I116044Follicular lymphoma grade 3, I116045Follicular lymphoma grade 3a, I116046Follicular lymphoma grade 3b, I116049Other types of follicular lymphoma, I17968Follicular lymphoma |
| ORPHAcodes (AIS) | 545Follicular lymphoma grade 1, 545Follicular lymphoma grade 2, 545Follicular lymphoma grade 3, 545Follicular lymphoma grade 3a, 545Follicular lymphoma grade 3b, 545Other types of follicular lymphoma, 545Follicular lymphoma |
| Therapeutic area | Oncological diseases Follicular lymphoma (FL) Orphan (turnover limit) |
| Reason for procedure | New therapeutic indication – Orphan turnover exceeded |
| Regulatory status | ATMP (CAR-T) |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Yescarta is used to treat adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after three or more systemic therapies |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with relapsed or refractory follicular lymphoma after three or more systemic therapies systemic therapies | Patient-individualised therapy with selection of: - Bendamustine + obinutuzumab followed by obinutuzumab maintenance therapy in accordance with the marketing authorisation, - Lenalidomide + rituximab, - Rituximab monotherapy, - mosunetuzumab, - tisagenlecleucel taking into account the previous therapy, the course of the disease and the patient's general condition. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (ZUMA-5) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + historical comparison |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The ZUMA-5 trial is an ongoing, single-arm, multicentre Phase II trial investigating the efficacy and safety of axicabtagen-ciloleucel in adult patients with indolent B-cell lymphoma, with the histological subtype restricted to grade 1, 2 or 3a follicular lymphoma or marginal zone lymphoma (according to the 2016 WHO classification).
- The SCHOLAR-5 study is a retrospective, multicentre study based on electronic health records, involving patients with relapsed or refractory indolent non-Hodgkin’s lymphoma.
Adults with relapsed or refractory follicular lymphoma following three or more courses of systemic therapy
- An additional benefit is not proven.
- Consequently, there are no suitable data available to enable an assessment of the additional benefit, which is why an additional benefit of axicabtagen-ciloleucel in patients with relapsed or refractory follicular lymphoma following three or more systemic therapies is not proven.
- Overall assessment
- The comparison presented of individual arms from the ZUMA-5 and SCHOLAR-5 studies is not suitable for benefit assessment of axicabtagen-ciloleucel, particularly due to the questionable structural equivalence between the treatment arms and the lack of systematic identification of potential confounders.
Courtesy translation only, please refer to the German original.
Associated procedures
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