The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
The FDA has approved a monthly subcutaneous dosing schedule for Johnson & Johnson's Rybrevant Faspro for EGFR-mutated NSCLC, based on PALOMA-2 trial data showing 82-87% response rates. The approval follows the drug's initial biweekly dosing approval in December 2025 and offers reduced administration time and reactions compared to intravenous delivery.
The FDA approved a once-monthly dosing schedule for Rybrevant Faspro with Lazcluze for first-line treatment of EGFR-mutated advanced NSCLC, reducing clinic visits while maintaining safety and efficacy established with bi-weekly dosing.