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Dossier assessment

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

Status
Status: Commission completed
Project no.
A21-86
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 718 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 718 kB, EN, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Adjuvant treatment of adult patients with stage IB to IIIA non-small cell lung cancer (NSCLC) with exon 19 deletion or exon 21 substitution mutation (L858R) of the epidermal growth factor receptor (EGFR) after complete tumour resection

Result of dossier assessment:
  • Without prior adjuvant platinum-based chemotherapy: added benefit not proven.
  • Patients after prior adjuvant platinum-based chemotherapy or for whom this therapy it is not suitable: hint of considerable added benefit.

Press releases

Adjuvant treatment of NSCLC: Certain patients benefit from osimertinib.

Hint of considerable added benefit if adjuvant platinum-based chemotherapy has already been administered after complete tumour resection or is not suitable.
Press release

Project details

Project no.
A21-86
Commission
Commission awarded on 23.06.2021 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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