Selpercatinib (3) – Retsevmo®
Thyroid carcinoma (MTC), RET fusion+, after sorafenib and/or lenvatinib pre-therapy
Characteristics
| Start date | 15.03.2021 – Marketing authorisation: 11.02.2021 |
|---|---|
| Resolution | 02.09.2021 |
| INN | Selpercatinib |
| Brand name | Retsevmo® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-657 |
| ATC code | L01EX22 Other protein kinase inhibitors (L01EX) |
| DDD | 0.32 g O |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
| Specialty | Bundling ACT change |
Studies and Results
- Clinical trials
- To demonstrate the additional benefit of selpercatinib, the pharmaceutical manufacturer has submitted the ongoing, uncontrolled, prospective basket trial LIBRETTO-001.
Adults with advanced thyroid carcinoma; with an existing RET receptor tyrosine kinase (rearranged during transfection – RET) fusion, for whom systemic therapy is indicated; following prior treatment with sorafenib and/or lenvatinib
- For the treatment of adults with advanced thyroid carcinoma; with a RET receptor tyrosine kinase (rearranged during transfection – RET) fusion, for whom systemic therapy is indicated; following prior treatment with sorafenib and/or lenvatinib, an additional benefit is not proven.
- The results from the LIBRETTO-001 study alone are not suitable for assessing the additional benefit of selpercatinib, as they do not allow for a comparison with the appropriate comparator therapy.
- It is not possible to assess additional benefit on the basis of this data. Consequently, additional benefit is not proven.
- No suitable data are available for assessing the additional benefit of selpercatinib compared with the appropriate comparator therapy. Consequently, additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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