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) |
| Therapeutic area | Oncological diseases |
| Reason for procedure | New therapeutic indication |
| Regulatory status | Conditional Approval |
| Specialty | Bundling |
Studies and Results
- 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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