J&J announces EC approved extension of marketing authorization for Rybrevant

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission has approved an extension of marketing authorization for a subcutaneous formulation of Rybrevant, in combination with Lazcluze, for the first-line treatment of adult patients with advanced non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. For these indications, it is recommended that SC amivantamab is administered weekly from Weeks 1 to 4, then every two weeks starting at Week 5 onwards, J&J noted.