[A25-159] Selpercatinib (RET fusion-positive NSCLC, first line) - Benefit assessment according to § 35a Social Code Book V (expiry of the limitation period)

Last updated 01.04.2026

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

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

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

Project no.	Title	Status
A25-71	Selpercatinib (RET mutant medullary thyroid cancer) – Benefit assessment according to §35a Social Code Book V	Commission completed
A24-63	Selpercatinib (solid tumours) - Benefit assessment according to § 35a Social Code Book V	Commission completed
A24-62	Selpercatinib (thyroid cancer) - Benefit assessment according to § 35a Social Code Book V	Commission completed
A22-106	Selpercatinib (thyroid cancer) – Benefit assessment according to §35a Social Code Book V	Commission completed
A22-65	Selpercatinib (advanced NSCLC with RET fusion) – Benefit assessment according to § 35a SGB V	Commission completed
A21-29	Selpercatinib (RET fusion-positive thyroid cancer) - Benefit assessment according to §35a Social Code Book V	Commission completed
A21-28	Selpercatinib (RET mutant medullary thyroid cancer) - Benefit assessment according to §35a Social Code Book V	Commission completed
A21-27	Selpercatinib (non-small cell lung cancer) - Benefit assessment according to §35a Social Code Book V	Commission completed
A26-71	Selpercatinib (RET-mutant medullary thyroid cancer, 2 to < 12 years) – Benefit assessment according to §35a Social Code Book V	Commission completed
A26-70	Selpercatinib (RET fusion-positive thyroid cancer, from 2 to < 12 years) – Benefit assessment according to §35a Social Code Book V	Commission completed
A26-69	Selpercatinib (RET fusion-positive solid tumours, from 2 to < 18 years) – Benefit assessment according to §35a Social Code Book V	Commission completed

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