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 |
Dossier: Ipsen Pharma GmbH
New distributor: Ipsen Pharma GmbH GB Specialty Care |
| G-BA Procedure ID | D-826 |
| ATC code | L01EX07 Other protein kinase inhibitors (L01EX) |
| ICD-10 codes (AIS) | C73Malignant neoplasm of thyroid gland |
| Alpha-ID codes (AIS) | I20616Thyroid carcinoma |
| DDD | 60 mg O |
| Therapeutic area | Oncological diseases Thyroid cancer (DTC / MTC) |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Cabometyx is indicated as monotherapy for the treatment of adults with locally advanced or metastatic differentiated thyroid carcinoma (DTC) who are refractory to or ineligible for radioiodine (RAI) and who have experienced progression during or after prior systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with locally advanced or metastatic differentiated thyroid carcinoma (DTC) who are refractory or ineligible for radioiodine (RAI) and have progression during or after prior systemic therapy. | Patient-specific therapy with choice of - sorafenib, - lenvatinib and - Best-Supportive-Care taking into account previous therapy and general condition |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
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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