Dossier assessment

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

Status
Status: Commission completed
Project no.
A22-05
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 443 kB, EN, not accessible
  2. Dossier assessment

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

    published on
    Document type
    PDF document, 736 kB, DE, not accessible

Dossier assessment

Indication:

Adult patients with locally advanced or metastatic NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based chemotherapy

Result of dossier assessment:
  • Patients for whom further chemotherapy is indicated: added benefit not proven.
  • Patients for whom no further therapy is indicated: added benefit not proven.

Press releases

Routine practice data in manufacturer dossiers: Things are not yet running smoothly

The criteria established by IQWiG in 2020 on routine practice data were positively received by the scientific community. However, there is still a lot of room for improvement in the implementation by the pharmaceutical industry.

Project details

Project no.
A22-05
Commission
Commission awarded on 17.01.2022 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.

Connected Projects

  1. Dossier assessment

    Amivantamab (NSCLC, combination with carboplatin and pemetrexed) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-10
    Last updated

    Status: Commission completed

  2. Dossier assessment

    Amivantamab (NSCLC, pretreated) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A25-09
    Last updated

    Status: Commission completed

  3. Dossier assessment

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

    Project no.
    A25-08
    Last updated

    Status: Commission completed

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