Fostamatinib (1) – Tavlesse®
Chronic immune thrombocytopenia
Characteristics
| Start date | 01.07.2020 – Marketing authorisation: 09.01.2020 |
|---|---|
| Resolution | 17.12.2020 |
| INN | Fostamatinib |
| Brand name | Tavlesse® |
| Pharm. company | Grifols Deutschland GmbH |
| G-BA Procedure ID | D-556 |
| ATC code | B02BX09 Other systemic hemostatics (B02BX) |
| ICD-10 codes (AIS) | D69.3Hemorrhagic (thrombocytopenic) purpura, D69.41Evans syndrome |
| Alpha-ID codes (AIS) | I1922Chronic idiopathic thrombocytopenia, I80017Primary thrombocytopenia |
| DDD | 0.2 g O |
| Therapeutic area | Hematopoietic diseases Immune thrombocytopenia (ITP), Thrombocytopenia |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
TAVLESSE is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adult patients with chronic immune thrombocytopenia refractory to other treatments | Eltrombopag or Romiplostim |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (Studie 047; Studie 048) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. non-ACT + no ITC |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 07.01.2020 – Änderung der Zulassung (EMA) |
- Clinical trials
- The randomised, controlled trials 047 and 048 were submitted for the assessment of the additional benefit of fostamatinib compared with the appropriate comparator therapy.
- Both studies were double-blind, multicentre registration trials with an identical study design, in which treatment with fostamatinib was compared with placebo in adult patients with persistent or chronic immune thrombocytopenia who had received at least one prior treatment.
Adult patients with chronic immune thrombocytopenia who are refractory to other treatments
- An additional benefit is not proven.
- In summary, on the basis of the studies submitted, no conclusions can be drawn regarding the additional benefit of fostamatinib compared with the appropriate comparator therapy.
- Due to the failure to implement the appropriate comparator therapy, it is not possible to assess the additional benefit.
- Overall assessment
- As the submitted placebo-controlled studies did not compare fostamatinib with the specified appropriate comparator therapy, these studies are not suitable for early benefit assessment.
Courtesy translation only, please refer to the German original.
Associated procedures
| Fostamatinib (1) | Tavlesse® | Grifols Deutschland GmbH | Chronic immune thrombocytopenia | 4,200–9,700 | 100% additional benefit not proven |
<< List of all resolutions