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Sotorasib (re-assessment: non-small cell lung cancer (NSCLC); KRAS G12C mutation; ≥ 1 previous therapy)

 

Subject:

  • Active Substance: Sotorasib
  • Name: Lumykras®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Amgen Europe B.V.

 

Time table:

  • Start: 01.02.2023
  • Publication of assessment: 02.05.2023
  • End of public hearing: 23.05.2023
  • Final decision by G-BA: middle of July 2023

 

Comparative therapy:

  1. After first-line therapy with a cytotoxic chemotherapy:
    - Docetaxel (only for patients with PD-L1 negative tumors) OR
    - pemetrexed (only for patients with PD-L1 negative tumors and except in cases of predominantly squamous histology) OR
    - nivolumab OR
    - pembrolizumab (only for patients with PD-L1 expressing tumors (TPS ≥ 1%)) OR
    - atezolizumab OR
    - docetaxel in combination with nintedanib (only for patients with PD-L1 negative tumors and adenocarcinoma histology)
     
  2. 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:
    A patient-individual therapy depending on prior therapy and histology choosing from afatinib, pemetrexed, erlotinib, docetaxel, docetaxel in combination with ramucirumab, docetaxel in combination with nintedanib and vinorelbine.