Dossier assessment

Repotrectinib (solid tumours with neurotrophic tyrosine receptor kinase [NTRK] gene fusion) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-58
Last updated

Report documents

  1. Extract of dossier assessment

    Repotrectinib (solid tumours with neurotrophic tyrosine receptor kinase [NTRK] gene fusion) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 320 kB, EN, PDF
    DOI-Link
    https://doi.org/10.60584/A25-58_en
  2. Dossier assessment

    Repotrectinib (solid tumours with neurotrophic tyrosine receptor kinase [NTRK] gene fusion) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 507 kB, DE, PDF
    DOI-Link
    https://doi.org/10.60584/A25-58

Dossier assessment

Indication:

Monotherapy for the treatment of adult and paediatric patients twelve years of age and older with advanced solid tumours expressing a NTRK gene fusion

Result of dossier assessment:
  • Patients who have not previously received an NTRK inhibitor and for whom treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted: added benefit not proven
  • Patients who have previously received an NTRK inhibitor: added benefit not proven.

Project details

Project no.
A25-58
Commission
Commission awarded on 30.04.2025 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.

DOI
https://doi.org/10.60584/A25-58

Connected Projects

  1. Dossier assessment

    Repotrectinib (NSCLC) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-59
    Last updated

    Status: Commission completed

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