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Dossier assessment

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

Status
Status: Commission completed
Project no.
A18-45
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 117 kB, not accessible
    Download file : Extract of dossier assessment (PDF document, 117 kB, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 861 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 861 kB, DE, not accessible)

Dossier assessment

Indication:

First-line treatment of adults with locally advanced or metastatic NSCLC (lung cancer) with activating EGFR mutations

Result of dossier assessment:

EGFR mutations in exon 21 (L858R) or exon 19 deletion: Hint of non-quantifiable added benefit. Other activating EGFR mutations: added benefit not proven

Project details

Project no.
A18-45
Commission
Commission awarded on 05.07.2018 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 (G-BA) 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 G-BA website.

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