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Dossier assessment

Trastuzumab deruxtecan (gastric or gastroesophageal junction adenocarcinoma) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-128
Last updated

Report documents

  1. Extract of dossier assessment

    Trastuzumab deruxtecan (gastric or gastroesophageal junction adenocarcinoma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 617 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-128_en
    Download file : Extract of dossier assessment (PDF document, 617 kB, EN, not accessible)

  2. Dossier assessment

    Trastuzumab deruxtecan (gastric or gastroesophageal junction adenocarcinoma) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-128
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with advanced HER2-positive gastric or GEJ adenocarcinoma who have received 1 prior trastuzumab-based regimen in first-line therapy

Result of dossier assessment:

Hint of considerable added benefit

Press releases

Trastuzumab deruxtecan for gastric cancer: now a considerable added benefit

Based on a comparative study initiated by the manufacturer prior to marketing authorization, IQWiG now sees a considerable added benefit of treatment with trastuzumab deruxtecan for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Press release

Additional information

Federal Joint Committee (G-BA)

19-03-2026 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-128
Commission
Commission awarded on 30.09.2025 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/A25-128_en

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  7. Addendum

    Trastuzumab deruxtecan (gastric or gastroesophageal junction adenocarcinoma) – Second addendum to Project A25-128

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    Status: Commission completed

  8. Addendum

    Trastuzumab deruxtecan (gastric or gastroesophageal junction adenocarcinoma) – Addendum to Project A25-128

    Project no.
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    Last updated

    Status: Commission completed

Contact

Press contact

+49 221 356850

press@iqwig.de

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