Duvelisib (2) – Copiktra®
Follicular lymphoma (FL), after ≥ 2 prior therapies
Characteristics
| Start date | 01.02.2022 – Marketing authorisation: 19.05.2021 |
|---|---|
| Resolution | 21.07.2022 |
| INN | Duvelisib |
| Brand name | Copiktra® |
| Pharm. company | Secura Bio Limited |
| G-BA Procedure ID | D-786 |
| ATC code | L01EM04 Pi3K inhibitors (L01EM) |
| 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, C82.7, C82.9Follicular lymphoma, unspecified |
| Alpha-ID codes (AIS) | I116042Follicular lymphoma grade 1, I116043Follicular lymphoma grade 2, I116044Follicular lymphoma grade 3, I116045Follicular lymphoma grade 3a, I116049Other types of follicular lymphoma, I17968Follicular lymphoma |
| DDD | 50 mg O |
| Therapeutic area | Oncological diseases Follicular lymphoma (FL) |
| Reason for procedure | Initial assessment |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Copiktra monotherapy is indicated for the treatment of adult patients with follicular lymphoma (FL) refractory to at least two prior systemic therapies. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with follicular lymphoma (FL) that is refractory to at least two prior systemic therapies. | Patient-specific therapy taking into account the previous therapy, the course of the disease and the general condition. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (DYNAMO) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + no comparison |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- For the benefit assessment, the pharmaceutical manufacturer submitted the results of the multicentre, open-label, single-arm DYNAMO (IPI-145-06) for the treatment of adults with follicular lymphoma refractory to at least two previous systemic therapies.
Adults with follicular lymphoma that is refractory to at least two previous systemic therapies
- An additional benefit is not proven.
- Overall, the results submitted from the DYNAMO study are not suitable for demonstrating additional benefit compared with the appropriate comparator therapy, as they do not allow for a comparison with the appropriate comparator therapy.
- Consequently, additional benefit from duvelisib as monotherapy in adult patients with follicular lymphoma that is refractory to at least two previous systemic therapies is not proven.
- mortality
- Further endpoints included overall survival [...]
- Conclusion
- Overall, the results presented from the DYNAMO study are not sufficient to demonstrate additional benefit over the appropriate comparator therapy, as they do not allow for a comparison with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Duvelisib (2) | Copiktra® | Secura Bio Limited | Follicular lymphoma (FL), after ≥ 2 prior therapies | 380–5,170 | 100% additional benefit not proven | |
| Duvelisib (1) | Copiktra® | Secura Bio Limited | Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies | 550–2,060 | 100% additional benefit not proven |
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