Dossier assessment

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

Status
Status: Commission completed
Project no.
A19-48
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 154 kB, EN, not accessible
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 364 kB, DE, not accessible

Dossier assessment

Indication:

Adults with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or after crizotinib and at least one other ALK TKI

Result of dossier assessment:

Added benefit versus appropriate comparator therapy not proven due to a lack of suitable study data

Additional information

Federal Joint Committee (G-BA)

2019-11-22 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-48
Commission
Commission awarded on 29.05.2019 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.

Connected Projects

  1. Dossier assessment

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

    Project no.
    A22-31
    Last updated

    Status: Commission completed

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