Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the subcutaneous (SC) formulation of RYBREVANT (amivantamab). This formulation is recommended for the first-line treatment of advanced EGFR-mutated non-small cell lung cancer (NSCLC) in combination with LAZCLUZE (lazertinib) and as monotherapy for patients with EGFR exon 20 insertion mutations after failure of platinum-based therapy.

The Phase 3 PALOMA-3 study demonstrated that SC amivantamab was non-inferior to the intravenous (IV) version in terms of pharmacokinetics, while also reducing infusion-related reactions five-fold and lowering the incidence of venous thromboembolic events. The new administration method reduces infusion time from five hours to just five minutes.

This milestone aligns with Johnson & Johnson’s commitment to enhancing patient experience and treatment accessibility for lung cancer. If approved by the European Commission, the subcutaneous formulation will offer a more convenient and safer alternative for NSCLC patients.