Posted by Michael Wonder on 07 Apr 2025
European Commission approves subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
7 April 2025 - European Commission approval based on positive results from the Phase 3 PALOMA-3 study.
Janssen-Cilag today announced that the European Commission has approved an extension of marketing authorisation for a subcutaneous formulation of Rybrevant (amivantamab), in combination with Lazcluze (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.
