Cabozantinib (Cabometyx, 6) – Cabometyx®
Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients
Characteristics
| Start date | 01.06.2022 – Marketing authorisation: 29.04.2022 |
|---|---|
| Resolution | 01.12.2022 |
| INN | Cabozantinib |
| Brand name | Cabometyx® |
| Pharm. company | Ipsen Pharma GmbH |
| G-BA Procedure ID | D-826 |
| ATC code | L01EX07 Other protein kinase inhibitors (L01EX) |
| DDD | 60 mg O |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
Adults with locally advanced or metastatic differentiated thyroid carcinoma (DTC) who are refractory to radioiodine (RAI) or for whom RAI is not an option, and who have shown disease progression during or after previous systemic therapy
- The additional benefit is not proven.
- For the treatment of adults with locally advanced or metastatic differentiated thyroid carcinoma (DTC) who are refractory to radioiodine (RAI) or are not eligible for it, and in whom disease progression has occurred during or after previous systemic therapy, the pharmaceutical manufacturer has not submitted any data for the assessment of additional benefit.
- Summary of the assessment
- The pharmaceutical manufacturer has not submitted any data that would enable an assessment of additional benefit. Additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Cabozantinib (Cabometyx, 6) | Cabometyx® | Ipsen Pharma GmbH | Thyroid carcinoma (MTC), refractory to radioiodine, pre-treated patients | 125–425 | 100% additional benefit not proven | |
| Cabozantinib (Cabometyx, 5) | Cabometyx® | Ipsen Pharma GmbH | Renal cell carcinoma (RCC), first-line, combination with nivolumab | 2,790–4,180 | 100% additional benefit not proven | |
| Cabozantinib (Cabometyx, 4) | Cabometyx® | Ipsen Pharma GmbH | Hepatocellular carcinoma (HCC) | 1,280–4,900 | 100% Hint for minor additional benefit | |
| Cabozantinib (Cabometyx, 3) | Cabometyx® | Ipsen Pharma GmbH | Renal cell carciRenal cell carcinoma (RCC), first-linenoma (RCC) | 2,240–2,570 | 100% additional benefit not proven | |
| Cabozantinib (Cabometyx, 2) | Cabometyx® | Ipsen Pharma GmbH | Renal cell carcinoma (RCC), after VEGF pre-therapy | 1,200–3,300 | 100% Indication of minor additional benefit | |
| Cabozantinib (Cabometyx, 1) | Cabometyx® | Ipsen Pharma GmbH | Renal cell carcinoma (RCC) |
0
1,200–3,300 |
100% Hint for non-quantifiable additional benefit repealed |
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