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Dossier assessment

Trifluridine/tipiracil (combination with bevacizumab; colorectal cancer) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-85
Last updated

Report documents

  1. Extract of dossier assessment

    Trifluridine/tipiracil (combination with bevacizumab; colorectal cancer) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 592 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 592 kB, EN, not accessible)

  2. Dossier assessment

    Trifluridine/tipiracil (combination with bevacizumab; colorectal cancer) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A23-85
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Combination therapy with bevacizumab for the treatment of adults with metastatic colorectal cancer who have received 2 prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor agents, and/or anti-epidermal growth factor receptor agents

Result of dossier assessment:

Indication of an unquantifiable, but at least considerable added benefit

Press releases

Early benefit assessment: Informative RCTs are also feasible in later lines of oncological treatment

Two randomized controlled trials in third- and fourth-line treatments for colorectal and breast cancer each show an added benefit for the drugs assessed.
Press release

Additional information

Federal Joint Committee (G-BA)

2024-02-15 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A23-85
Commission
Commission awarded on 15.08.2023 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://dx.doi.org/10.60584/A23-85

Connected Projects

  1. Addendum

    Trifluridine/tipiracil (combination with bevacizumab; colorectal cancer) – Addendum to Project A23-85

    Project no.
    A24-09
    Last updated

    Status: Commission completed

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