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Dossier assessment

Ivosidenib (cholangiocarcinoma) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A26-20
Last updated

Report documents

  1. Extract of dossier assessment

    Ivosidenib (cholangiocarcinoma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 258 kB, DE, not accessible
    Download file : Extract of dossier assessment (PDF document, 258 kB, DE, not accessible)

  2. Dossier assessment

    Ivosidenib (cholangiocarcinoma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 698 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A26-20
    Download file : Dossier assessment (PDF document, 698 kB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

    Ivosidenib (cholangiocarcinoma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 204 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 204 kB, EN, not accessible)

Dossier assessment

Indication:

Adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 R132 mutation who were previously treated by at least one prior line of systemic therapy

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A26-20
Commission
Commission awarded on 02.03.2026 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/A26-20

Connected Projects

  1. Dossier assessment

    Ivosidenib (cholangiocarcinoma) – Assessment according to §35a (para. 1, sentence 11) Social Code Book V

    Project no.
    G23-15
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Ivosidenib (acute myeloid leukaemia, IDH1 R132 mutation, first line, combination with azacitidine) – Assessment according to §35a (para. 1, sentence 11) Social Code Book V

    Project no.
    G23-16
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Ivosidenib (acute myeloid leukaemia) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-19
    Last updated

    Status: Commission completed

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