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Dossier assessment

Selpercatinib (RET mutant medullary thyroid cancer) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-71
Last updated

Report documents

  1. Extract of dossier assessment

    Selpercatinib (RET mutant medullary thyroid cancer) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 675 kB, EN, PDF
    DOI-Link
    https://doi.org/10.60584/A25-71_V1.1_en
    Download file : Extract of dossier assessment (PDF-Dokument, 675 kB, EN, PDF)

  2. Dossier assessment

    Selpercatinib (RET mutant medullary thyroid cancer) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 3 MB, DE, PDF
    DOI-Link
    https://doi.org/10.60584/A25-71_V1.1
    Download file : Dossier assessment (PDF-Dokument, 3 MB, DE, PDF)

Dossier assessment

Indication:

Adults and adolescents 12 years and older with advanced rearranged during transfection-mutant medullary thyroid cancer; first-line therapy

Result of dossier assessment:

Indication of major added benefit

Press releases

Selpercatinib in medullary thyroid cancer: RCT shows substantial survival advantages

Following the expiry of the first decision: Reassessment of the drug for the first-line treatment of RET-mutant medullary thyroid cancer shows an indication of a major added benefit.
Press release

Project details

Project no.
A25-71
Commission
Commission awarded on 28.05.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the GBA website.

The current version 1.1 of the dossier assessment replaces version 1.0 published on 2025-09-01.

DOI
https://doi.org/10.60584/A25-71_V1.1

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  9. Dossier assessment

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  11. Dossier assessment

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