[A21-168] Pralsetinib (RET fusion-positive NSCLC) - Benefit assessment according to §35a Social Code Book V
Last updated 15.03.2022
Project no.:
A21-168
Commission:
Commission awarded on 14.12.2021 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Cancer
Indication:
Patients with advanced rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) who have previously not been treated with a RET inhibitor
Result of dossier assessment:
- Adults with advanced RET fusion-positive NSCLC whose tumours have PD-L1 expression ≥ 50% of the tumour cells; first-line therapy: added benefit not proven
- Adults with advanced RET fusion-positive NSCLC whose tumours have PD-L1 expression < 50% of the tumour cells; first-line therapy: added benefit not proven
- Adults with advanced RET fusion-positive NSCLC after first-line therapy with a PD-1/PD-L1 antibody as monotherapy: added benefit not proven
- Adults with advanced RET fusion-positive NSCLC after first-line therapy with cytotoxic chemotherapy: added benefit not proven
- Adults with advanced RET fusion-positive NSCLC after first-line therapy with a PD-1/PD-L1 antibody in combination with platinum-containing chemotherapy or after sequential therapy with a PD-1/PD-L1 antibody and a platinum-containing chemotherapy: added benefit not proven.
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.