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Dossier assessment

Dostarlimab (endometrial cancer) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-84
Last updated

Report documents

  1. Extract of dossier assessment

    Dostarlimab (endometrial cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 391 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 391 kB, EN, not accessible)

  2. Dossier assessment

    Dostarlimab (endometrial cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 588 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 588 kB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with mismatch repair deficient/microsatellite instability-high recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen

Result of dossier assessment:

Added benefit not proven.

Press releases

Routine practice data in manufacturer dossiers: Things are not yet running smoothly

The criteria established by IQWiG in 2020 on routine practice data were positively received by the scientific community. However, there is still a lot of room for improvement in the implementation by the pharmaceutical industry.
Press release

Additional information

Federal Joint Committee (G-BA)

2021-12-02 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A21-84
Commission
Commission awarded on 16.06.2021 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. Addendum

    Dostarlimab (endometrial cancer) - Addendum to commission A21-84

    Project no.
    A21-139
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Dostarlimab (endometrial cancer) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A23-143
    Last updated

    Status: Commission completed

  3. Addendum

    Dostarlimab (endometrial cancer) - Second addendum to commission A21-84

    Project no.
    G21-31
    Last updated

    Status: Commission completed

  4. Dossier assessment

    Dostarlimab (endometrial cancer, pMMR) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-24
    Last updated

    Status: Commission completed

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