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) |
| ICD-10 codes (AIS) | C73Malignant neoplasm of thyroid gland |
| Alpha-ID codes (AIS) | I20616Thyroid carcinoma |
| DDD | 0.32 g O |
| Therapeutic area | Oncological diseases Thyroid cancer (DTC / MTC) |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
| Specialty | Bundling ACT change |
| Therapeutic indication of the resolution |
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Retsevmo as monotherapy is indicated for the treatment of adults with advanced RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib |
| Subpopulation | Indication | Comparator |
|---|---|---|
| C) | Adults with advanced thyroid carcinoma; with existing RET receptor tyrosine kinase fusion (rearranged during transfection - RET) in whom systemic therapy is indicated; after previous therapy with sorafenib and/or lenvatinib. | Patient-specific therapy with choice of - sorafenib, - lenvatinib and - best-supportive care taking into account histology, previous therapy and general condition |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
| ACT change | 19.01.2021 – Stellungnahme der Fachgesellschaften |
- 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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