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Dossier assessment

Lazertinib (NSCLC, first line, in combination with amivantamab) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-11
Last updated

Report documents

  1. Extract of dossier assessment

    Lazertinib (NSCLC, first line, in combination with amivantamab) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 704 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-11_en
    Download file : Extract of dossier assessment (PDF document, 704 kB, EN, not accessible)

  2. Dossier assessment

    Lazertinib (NSCLC, first line, in combination with amivantamab) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 1 MB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-11
    Download file : Dossier assessment (PDF document, 1 MB, DE, not accessible)

Dossier assessment

Indication:

Adult patients with advanced non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations; first-line treatment

Result of dossier assessment:
  • Patients < 65 years: hint of a non-quantifiable added benefit
  • Patients ≥ 65 years: hint of lesser benefit

Additional information

Federal Joint Committee (G-BA)

17.07.2025 A G-BA decision was published.
G-BA documents on this decision

Project details

Project no.
A25-11
Commission
Commission awarded on 12.02.2025 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/A25-11_en

Connected Projects

  1. Addendum

    Amivantamab (NSCLC, first line, combination with lazertinib) - Addendum to Project A25-08

    Project no.
    A25-78
    Last updated

    Status: Commission completed

  2. Addendum

    Lazertinib (NSCLC, first line, combination with amivantamab) - Addendum to Project A25-11

    Project no.
    A25-77
    Last updated

    Status: Commission completed

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