Johnson & Johnson Receives FDA Approval for Subcutaneous Rybrevant in NSCLC

Johnson & Johnson today announced that the FDA has approved a subcutaneous (SC) formulation of Rybrevant (amivantamab-vmjw) for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The SC formulation offers a more convenient administration option compared to the existing intravenous (IV) formulation. In the Phase 3 PALOMA-3 trial, the SC formulation demonstrated comparable pharmacokinetics and efficacy to the IV formulation. The SC injection can be administered in approximately 5 minutes compared to the multi-hour IV infusion. This approval expands the administration options for Rybrevant in NSCLC.