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Dossier assessment

Osimertinib (locally advanced, unresectable NSCLC) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-03
Last updated

Report documents

  1. Extract of dossier assessment

    Osimertinib (locally advanced, unresectable NSCLC) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 339 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-03_en
    Download file : Extract of dossier assessment (PDF document, 339 kB, EN, not accessible)

  2. Dossier assessment

    Osimertinib (locally advanced, unresectable NSCLC) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 563 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-03
    Download file : Dossier assessment (PDF document, 563 kB, DE, not accessible)

Dossier assessment

Indication:

Adults with locally advanced, unresectable non-small cell lung cancer whose tumours have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy

Result of dossier assessment:
  • Patients whose tumours express PD-L1 in ≥ 1% of tumour cells: added benefit not proven
  • Patients whose tumours express PD-L1 in < 1% of tumour cells: added benefit not proven

Additional information

Federal Joint Committee (G-BA)

03.07.2025 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-03
Commission
Commission awarded on 13.01.2025 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/A25-03_en

Connected Projects

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  4. Dossier assessment

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  5. Dossier assessment

    Osimertinib (NSCLC) - Benefit assessment according to §35a Social Code Book V

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  6. Dossier assessment

    Osimertinib - Benefit assessment according to §35a Social Code Book V

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    Status: Commission completed

  7. Addendum

    Osimertinib (locally advanced, unresectable NSCLC) – Addendum to Project A25-03

    Project no.
    G25-20
    Last updated

    Status: Commission completed

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