Dossier assessment

Serplulimab (NSCLC) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A26-89
Last updated

Report documents

  1. Extract of dossier assessment

    Serplulimab (NSCLC) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 199 kB, DE, not accessible
  2. Dossier assessment

    Serplulimab (NSCLC) – 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/A26-89

Dossier assessment

Indication:

First-line treatment of non-squamous non-small cell lung carcinoma (NSCLC), with no epidermal growth factor receptor, anaplastic lymphoma kinase or c-ros oncogene 1 aberrations, in adult patients who have locally advanced NSCLC and are not candidates for surgery or radiotherapy, or who have metastatic NSCLC

Result of dossier assessment:
  • Patients with programmed cell death-ligand 1 (PD-L1) expression on ≥50% of tumour cells: added benefit not proven
  • Patients with PD-L1 expression on <50% of tumour cells: added benefit not proven

Project details

Project no.
A26-89
Commission
Commission awarded on 23.07.2026 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/A26-89

Connected Projects

  1. Dossier assessment

    Serplulimab (small cell lung cancer, first line) – Assessment according to §35a (para. 1, sentence 11) Social Code Book V

    Project no.
    G25-18
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Serplulimab (squamous NSCLC) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A26-91
    Last updated

    Status: Commission completed

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