Vandetanib (4) – Caprelsa®
Thyroid carcinoma (MTC)
Characteristics
| Start date | 01.10.2021 – Marketing authorisation: 17.02.2012 |
|---|---|
| Resolution | 18.03.2022 |
| INN | Vandetanib |
| Brand name | Caprelsa® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-738 |
| ATC code | L01EX04 Other protein kinase inhibitors (L01EX) |
| DDD | 0.3 g O |
| Therapeutic area | Oncological diseases |
| Reason for procedure |
Reassessment: G-BA limitation
Original resolution: Vandetanib (2) (05.09.2013) |
| Regulatory status | Conditional Approval |
| Specialty | ACT change |
Studies and Results
Adults with aggressive and symptomatic medullary thyroid carcinoma (MTC) and unresectable, locally advanced or metastatic disease
- Additional benefit is not proven for the treatment of adults with aggressive and symptomatic medullary thyroid carcinoma (MTC) and unresectable, locally advanced or metastatic disease.
- The results of study D4200C00104 alone are not suitable for assessing the additional benefit of vandetanib, as they do not allow for a comparison with the appropriate comparator therapy.
- Consequently, no data are available for assessing the additional benefit of vandetanib compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Vandetanib (4) | Caprelsa® | Sanofi-Aventis Deutschland GmbH | Thyroid carcinoma (MTC) | 50–670 | 100% additional benefit not proven | |
| Vandetanib (3) | Caprelsa® | Genzyme GmbH | Thyroid carcinoma, ≥ 5 years |
0
2–8 |
100% Hint for non-quantifiable additional benefit repealed | |
| Vandetanib (2) | Caprelsa® | AstraZeneca GmbH | Thyroid carcinoma (MTC) |
0
60–1,500 |
100% Hint for minor additional benefit repealed | |
| Vandetanib (1) | Caprelsa® | AstraZeneca GmbH | Thyroid carcinoma (MTC) |
0
130–1,300 |
100% additional benefit not proven repealed |
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