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Dossier assessment

Tislelizumab (NSCLC, second line) - Benefit assessment according to § 35a Social Code Book (SGB) V

Status
Status: Commission completed
Project no.
A24-128
Last updated

Report documents

  1. Extract of dossier assessment

    Tislelizumab (NSCLC, second line) - Benefit assessment according to § 35a Social Code Book (SGB) V

    published on
    Document type
    PDF document, 616 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-128_en
    Download file : Extract of dossier assessment (PDF document, 616 kB, EN, not accessible)

  2. Dossier assessment

    Tislelizumab (NSCLC, second line) - Benefit assessment according to § 35a Social Code Book (SGB) V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A24-128
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior treatment with platinum-based chemotherapy; in addition, patients with epidermal growth factor receptor mutant or anaplastic lymphoma kinase positive NSCLC should also have received targeted therapies before receiving tislelizumab.

Result of dossier assessment:
  • Patients with PD-L1 negative tumours: hint of non-quantifiable added benefit
  • Patients with PD-L1 positive tumours: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

18.06.2025 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A24-128
Commission
Commission awarded on 20.12.2024 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/A24-128_en

Connected Projects

  1. Dossier assessment

    Tislelizumab (gastric or gastroesophageal junction adenocarcinoma, HER2-negative) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A24-131
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Tislelizumab (oesophageal squamous cell carcinoma, first line) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A24-129
    Last updated

    Status: Commission completed

  3. Dossier assessment

    Tislelizumab (squamous NSCLC, first line) – Benefit assessment according to §35a Social Code Book (SGB) V

    Project no.
    A24-126
    Last updated

    Status: Commission completed

  4. Addendum

    Tislelizumab (NSCLC, second line or later) – Addendum to Project A24-128

    Project no.
    A25-63
    Last updated

    Status: Commission completed

  5. Dossier assessment

    Tislelizumab (NSCLC, neoadjuvant + adjuvant) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-122
    Last updated

    Status: Commission completed

  6. Dossier assessment

    Tislelizumab (nasopharyngeal carcinoma) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-119
    Last updated

    Status: Commission completed

  7. Dossier assessment

    Tislelizumab (small cell lung cancer, extensive stage) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-118
    Last updated

    Status: Commission completed

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