FDA Approves Subcutaneous Amivantamab for EGFR-Mutated NSCLC
The FDA approved subcutaneous amivantamab for EGFR-mutated NSCLC in December 2025 based on phase 3 PALOMA-3 trial data showing noninferior efficacy with reduced infusion reactions and 5-minute administration time. The formulation decreases infusion-related reactions from 66% to 13% and improves patient convenience and quality of life. Recent MARIPOSA trial updates show amivantamab plus lazertinib extends median overall survival by at least 12 months versus osimertinib monotherapy.