Dossier assessment

Selpercatinib (RET fusion-positive NSCLC, first line) - Benefit assessment according to § 35a Social Code Book V (expiry of the limitation period)

Status
Status: Commission completed
Project no.
A25-159
Last updated

Report documents

  1. Extract of dossier assessment

    Selpercatinib (RET fusion-positive NSCLC, first line) - Benefit assessment according to § 35a Social Code Book V (expiry of the limitation period)

    published on
    Document type
    PDF document, 275 kB, DE, not accessible
  2. Dossier assessment

    Selpercatinib (RET fusion-positive NSCLC, first line) - Benefit assessment according to § 35a Social Code Book V (expiry of the limitation period)

    published on
    Document type
    PDF document, 788 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-159

Drug assessment at a glance

  1. Drug assessment at a glance

    Selpercatinib (RET fusion-positive NSCLC, first line) - Benefit assessment according to § 35a Social Code Book V (expiry of the limitation period)

    published on
    Document type
    PDF document, 214 kB, EN, not accessible

Dossier assessment

Indication:

Adults with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor

Result of dossier assessment:
  • Patients with PD-L1 expression ≥ 50% of tumour cells; first line therapy: added benefit not proven
  • Patients with PD-L1 expression < 50% of tumour cells; first line therapy: added benefit not proven

Project details

Project no.
A25-159
Commission
Commission awarded on 01.01.2026 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/A25-159

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