Subject:
- Active Substance: Pralsetinib
- Name: Gavreto®
- Therapeutic area: Non-small cell lung cancer (NSCLC)
- Pharmaceutical company: Roche Registration GmbH
Time table:
- Start: 15.12.2021
- Final decision by G-BA: 16.06.2022
Final decision:
- Adult patients with PD-L1 expression ≥ 50% of tumor cells; first-line therapy: No additional benefit proved
- Adult patients with PD-L1 expression ≤ 50% of tumor cells; first-line therapy: No additional benefit proved
- Adult patients after first-line therapy with a PD-1/PD-L1 antibody as monotherapy: No additional benefit proved
- Adult patients after first-line therapy with cytotoxic chemotherapy: No additional benefit proved
- Adult patients 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 platinum-containing chemotherapy: No additional benefit proved