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Dossier assessment

Entrectinib (solid tumours with a neurotrophic tyrosine receptor kinase [NTRK] gene fusion, > 1 month to < 12 years) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A24-78
Last updated

Report documents

  1. Extract of dossier assessment

    Entrectinib (solid tumours with a neurotrophic tyrosine receptor kinase [NTRK] gene fusion, > 1 month to < 12 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 324 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-78_en
    Download file : Extract of dossier assessment (PDF document, 324 kB, EN, not accessible)

  2. Dossier assessment

    Entrectinib (solid tumours with a neurotrophic tyrosine receptor kinase [NTRK] gene fusion, > 1 month to < 12 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 988 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-78
    Download file : Dossier assessment (PDF document, 988 kB, DE, not accessible)

Dossier assessment

Indication:

Paediatric patients (1 month to less than 12 years of age) with solid tumours that have a neurotrophic tyrosine receptor kinase gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior neurotrophic tyrosine receptor kinase inhibitor, and who have no satisfactory treatment options other than larotrectinib

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A24-78
Commission
Commission awarded on 31.07.2024 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/A24-78_en

Connected Projects

  1. Dossier assessment

    Entrectinib (solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-74
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Entrectinib (NSCLC) - Benefit assessment according to §35a Social Code Book V

    Project no.
    A20-75
    Last updated

    Status: Commission completed

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