Selpercatinib (2) – Retsevmo®
Medullary thyroid carcinoma (MTC), RET-mutated, after cabozantinib and/or vandetanib prior therapy, ≥ 12 years
Characteristics
| Start date | 15.03.2021 – Marketing authorisation: 11.02.2021 |
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| Resolution | 02.09.2021 |
| INN | Selpercatinib |
| Brand name | Retsevmo® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-656 |
| ATC code | L01EX22 Other protein kinase inhibitors (L01EX) |
| ICD-10 codes (AIS) | C73Malignant neoplasm of thyroid gland |
| Alpha-ID codes (AIS) | I20615Medullary thyroid 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 and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with cabozantinib and/or vandetanib. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults and adolescents aged 12 years and older with advanced medullary thyroid carcinoma (MTC); with RET receptor tyrosine kinase (rearranged during transfection - RET) mutation for whom systemic therapy is indicated; after previous therapy with cabozantinib and/or vandetanib. | Patient-specific therapy with selection of - cabozantinib, - vandetanib and - Best-Supportive-Care taking into account 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 | 09.02.2021 – Stellungnahmen der Fachgesellschaften |
Adults and adolescents aged 12 years and over with advanced medullary thyroid carcinoma (MTC); with a RET receptor tyrosine kinase (rearranged during transfection – RET) mutation, for whom systemic therapy is indicated; following prior treatment with cabozantinib and/or vandetanib
- For the treatment of adults and adolescents aged 12 years and over with advanced medullary thyroid carcinoma (MTC); with a RET receptor tyrosine kinase (rearranged during transfection – RET) mutation; in whom systemic therapy is indicated; following prior treatment with cabozantinib and/or vandetanib, additional benefit is not proven.
- Consequently, there are no suitable data available for assessing the additional benefit of selpercatinib compared with the appropriate comparator therapy. Therefore, the 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.
- The pharmaceutical manufacturer has submitted a non-adjusted indirect comparison. The comparisons of individual arms from the EXAM study that have been submitted are not suitable for drawing conclusions regarding additional benefit, as not all inclusion criteria relevant to the research question were met in the study.
- Furthermore, the bias resulting from the comparison of individual arms from different studies – in terms of both magnitude and direction – cannot be assessed even on the basis of the sensitivity analyses provided.
- Moreover, the observed effects are not so large that they cannot be explained solely by bias.
- Overall assessment
- No suitable data are available for assessing the additional benefit of selpercatinib compared with the appropriate comparator therapy. Consequently, additional benefit is not proven.
- Selpercatinib may represent a relevant treatment option in individual cases within the indicated therapeutic indication.
Courtesy translation only, please refer to the German original.
Associated procedures
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