Selpercatinib (6) – Retsevmo®
Thyroid carcinoma, RET fusion+, refractory to radioiodine, first-line or after systemic prior therapy, ≥ 12 years of age
Characteristics
| Start date | 15.05.2024 – Marketing authorisation: 29.02.2024 |
|---|---|
| Resolution | 07.11.2024 |
| INN | Selpercatinib |
| Brand name | Retsevmo® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-1061 |
| ATC code | L01EX22 Other protein kinase inhibitors (L01EX) |
| ICD-10 codes (AIS) | C73Malignant neoplasm of thyroid gland |
| Alpha-ID codes (AIS) | I20616Thyroid carcinoma |
| Therapeutic area | Oncological diseases Thyroid cancer (DTC / MTC) |
| Reason for procedure | New therapeutic indication |
| Regulatory status | Conditional Approval |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
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Retsevmo as monotherapy is used for the treatment of adults and adolescents aged 12 years and older with advanced RET fusion-positive thyroid cancer that is refractory to radioactive iodine (when radioactive iodine is appropriate); first-line therapy. Retsevmo as monotherapy is used for the treatment of adolescents aged 12 years and older with advanced RET fusion-positive thyroid carcinoma; following prior therapy with a protein kinase inhibitor. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adults and adolescents aged 12 years and older with advanced RET fusion-positive, radioiodine-refractory thyroid carcinoma, first-line therapy | - Sorafenib or - Lenvatinib (for adults only) |
| b) | Adolescents aged 12 years and older with advanced RET fusion-positive thyroid carcinoma, after previous therapy with a protein kinase inhibitor | Patient-individualised therapy under selection of – sorafenib, – lenvatinib and – Best supportive care, taking into account previous therapy and general condition |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (LIBRETTO-001, LIBRETTO-121) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
- Clinical trials
- The LIBRETTO-001 trial is a multicentre, single-arm, prospective, two-phase basket trial that has been ongoing since 2017.
- The LIBRETTO-121 trial is a multicentre, single-arm, prospective basket trial that has been ongoing since 2019 and is also being conducted in two phases.
a) Adults and adolescents aged 12 years and over with advanced RET-fusion-positive, radioiodine-refractory thyroid cancer, first-line treatment
- The additional benefit is not proven.
- For the benefit assessment, the pharmaceutical manufacturer has submitted the results of the LIBRETTO-001 and LIBRETTO-121 studies. Due to their single-arm study design, the LIBRETTO-001 and LIBRETTO-121 studies do not allow for a comparison with the appropriate comparator therapy and are therefore not suitable for assessing the additional benefit of selpercatinib.
b) Adolescents aged 12 years and over with advanced RET-fusion-positive thyroid carcinoma, following prior treatment with a protein kinase inhibitor
- An additional benefit is not proven.
- The pharmaceutical manufacturer has not submitted any data that would enable an assessment of the additional benefit.
Courtesy translation only, please refer to the German original.
Associated procedures
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