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Dossier assessment

Cemiplimab (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A21-98
Last updated

Report documents

  1. Extract of dossier assessment

    Cemiplimab (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 748 kB, EN, PDF
    Download file : Extract of dossier assessment (PDF-Dokument, 748 kB, EN, PDF)

  2. Dossier assessment

    Cemiplimab (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF-Dokument, 873 kB, DE, PDF
    Download file : Dossier assessment (PDF-Dokument, 873 kB, DE, PDF)

Dossier assessment

Indication:

First-line treatment of adult patients with non-small cell lung cancer (NSCLC) whose tumours express programmed cell death ligand 1 (PD-L1) in ≥ 50% of the tumour cells and have no aberrations due to epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or C-ros oncogene 1 (ROS1)

Treatment is intended for patients with locally advanced NSCLC who are not candidates for definitive radiochemotherapy or patients with metastatic NSCLC

Result of dossier assessment:

Added benefit not proven.

Project details

Project no.
A21-98
Commission
Commission awarded on 21.07.2021 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.

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