Posted by Michael Wonder on 04 Feb 2025
CHMP recommends subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR mutated non-small cell lung cancer
3 February 2025 - Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous thromboembolic events.
Janssen-Cilag today announced that the CHMP of the EMA has recommended 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.
