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Dossier assessment

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

Status
Status: Commission completed
Project no.
A20-74
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 478 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 478 kB, EN, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 921 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 921 kB, DE, not accessible)

Dossier assessment

Indication:

Solid tumours expressing an NTRK gene fusion, disease locally advanced or metastatic or where surgical resection is likely to result in severe morbidity: patients 12 years of age and older who have not received a prior NTRK inhibitor and who have no satisfactory treatment options

Result of dossier assessment:

Added benefit not proven due to lack of suitable study data

Additional information

Federal Joint Committee (G-BA)

2021-02-18: A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A20-74
Commission
Commission awarded on 28.08.2020 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.

Connected Projects

  1. Dossier assessment

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

    Project no.
    A20-75
    Last updated

    Status: Commission completed

  2. Addendum

    Entrectinib (solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion) - Addendum to Commission A20-74

    Project no.
    A21-07
    Last updated

    Status: Commission completed

  3. 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

    Project no.
    A24-78
    Last updated

    Status: Commission completed

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