CHMP

  • December 16 – lorlatinib – NSCLC ALK fusions: EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the extension of indication for lorlatinib in order to include adult patients with ALK positive advanced NSCLC previously not treated with an ALK inhibitor.
  • December 16 – tepotinib – NSCLC skipping METex14: EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of tepotinib as monotherapy for the treatment of adult patients with advanced NSCLC harbouring alterations leading to MET gene exon 14 skipping of (METex14), who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

EMA

  • December 10- amivantamab – NSCLC EGFR ex20ins: EMA granted conditional marketing authorization for amivantamab for the treatment of adult patients with advanced NSCLC with EGFR exon 20 insertion, after failure of platinum-based therapy.
  • January 9 – sotorasib – NSCLC KRAS G12C: EMA granted conditional marketing authorization for sotorasib for the treatment of adult patients with advanced NSCLC with KRAS G12C mutation, who have progressed after at least one prior line of systemic therapy.