[ A21-86] Osimertinib (NSCLC) - Benefit assessment according to §35a Social Code Book V

Last updated 01.10.2021

Project no.:
A21-86

Commission:
Commission awarded on 23.06.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

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.
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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