Dossier assessment

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

Status
Status: Commission completed
Project no.
A19-39
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF-Dokument, 595 kB, EN, PDF
  2. Dossier assessment

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

    published on
    Document type
    PDF-Dokument, 2 MB, DE, PDF

Dossier assessment

Indication:

Adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations

Result of dossier assessment:

Patients with L858R or Del19 mutations: Advantages in overall survival and individual side effects are offset by numerous disadvantages in several outcome categories. Other mutations: No data available. Added benefit not proven for either of both research questions.

Press releases

Dacomitinib in advanced lung cancer: large number of disadvantages outweighs survival advantage

Longer survival is offset by partly severe side effects and deterioration in symptoms and quality of life

Additional information

Federal Joint Committee (G-BA)

2019-10-17 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-39
Commission
Commission awarded on 29.04.2019 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.

Contact

Info Service (German)

Subscribe to daily updated information on projects, calls for tender, current vacancies and events as well as our press releases.

Register

Contact form

Questions about commissions, publications and press releases can be sent to us via this form.

Contact form