Posted by Michael Wonder on 18 Dec 2025
FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
17 December 2025 - Today, the FDA approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech).
The subcutaneous injection of amivantamab and hyaluronidase-lpuj was evaluated in PALOMA-3, a randomised, open-label, multi-centre, multi-regional trial in adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR-exon 19 deletions or exon 21 L858R substitution mutations.
