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Dossier assessment

Pembrolizumab (TNBC, neoadjuvant and adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)

Status
Status: Commission completed
Project no.
A24-104
Last updated

Report documents

  1. Extract of dossier assessment

    Pembrolizumab (TNBC, neoadjuvant and adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF document, 644 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-104_en
    Download file : Extract of dossier assessment (PDF document, 644 kB, EN, not accessible)

  2. Dossier assessment

    Pembrolizumab (TNBC, neoadjuvant and adjuvant) – Benefit assessment according to §35a Social Code Book V (expiry of the decision)

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-104
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery

Result of dossier assessment:
  • Patients for whom paclitaxel + carboplatin followed by doxorubicin or epirubicin + cyclophosphamide is the suitable neoadjuvant chemotherapy of physician’s choice: hint of minor added benefit
  • Patients for whom paclitaxel + carboplatin followed by doxorubicin or epirubicin + cyclophosphamide is not the suitable neoadjuvant chemotherapy of physician’s choice: added benefit not proven

Project details

Project no.
A24-104
Commission
Commission awarded on 30.09.2024 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/A24-104_en

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