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Dossier assessment

Ipilimumab (non-small cell lung cancer, combination with nivolumab) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A20-116
Last updated

Report documents

  1. Extract of dossier assessment

    Ipilimumab (non-small cell lung cancer, combination with nivolumab) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 696 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 696 kB, EN, not accessible)

  2. Dossier assessment

    Ipilimumab (non-small cell lung cancer, combination with nivolumab) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 825 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 825 kB, DE, not accessible)

Dossier assessment

Indication:

First-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitizing EGFR mutation or ALK translocation.

Result of dossier assessment:

PD-L1 expression (TPS) of at least 50 percent: added benefit not proven.

PD-L1 expression (TPS) below 50 percent: non-squamous histology: indication of added benefit; extent “non-quantifiable". Squamous histology: added benefit not proven.

Additional information

Federal Joint Committee (G-BA)

2021.06.04 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A20-116
Commission
Commission awarded on 14.12.2020 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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