FDA Expands Amivantamab With Once-Monthly Subcutaneous Dosing
Clinical Summary:
- The FDA approval was supported by findings from the phase 2 PALOMA-2 study evaluating once-monthly subcutaneous amivantamab in combination with lazertinib for patients with EGFR-mutated metastatic non-small cell lung cancer (NSCLC).
- Once-monthly subcutaneous amivantamab demonstrated high response rates with pharmacokinetic exposure comparable to previous dosing schedules while reducing administration-related reactions. The subcutaneous formulation also shortened administration time to approximately 5 minutes and showed a favorable safety profile.
- This approval introduces a more convenient dosing schedule that may reduce treatment burden while maintaining the clinical activity of amivantamab for patients with EGFR-mutated metastatic NSCLC.
Danny Nguyen, MD, City of Hope, Orange County, California, discusses the recent FDA approval of once-monthly subcutaneous amivantamab in combination with lazertinib for patients with EGFR-mutated metastatic non-small cell lung cancer. The approval was based on phase 2 PALOMA-2 data evaluating the efficacy, pharmacokinetics, and safety of the simplified dosing schedule.
The subcutaneous formulation substantially reduces administration time compared with intravenous amivantamab while maintaining clinical activity and improving tolerability through fewer administration-related reactions. These findings support a more convenient treatment option that may lessen the burden of therapy for patients receiving first-line EGFR-targeted treatment.
Transcript:
Hi, my name is Danny Nguyen, and I'm a medical oncologist at City of Hope in California. I'm here to talk about the recent FDA approval for subcutaneous amivantimab, specifically the every 4-week indication for subcutaneous amivantimab, for EGFR-mutated non-small cell lung cancer patients who are metastatic. The subcutaneous amivantimab is combined with ora lazertinib for these patients.
I think this is a win for specifically patients having a more convenient dosing schedule that's more consistent with their lives. There's still a weekly dosing for 4 weeks and then transition every 4 weeks with this regimen. This is important because the subcutaneous amivantimab is given over 5 minutes as opposed to approximately 5 hours with the intravenous formulation of amivantimab. The subcutaneous form of amivantimab also has less administration-related reactions and there also is some suggestions of a decreased risk of thrombosis with this regimen.
The PALOMA-2 data, for which this subcutaneous amivantimab every 4 week dosing is based on, suggested or showed that patients still had a high response rate with this regimen and so far, the overall survival, PFS, duration response has not yet read out at 6 and a half months just yet.
Sources:
- Johnson and Johnson. FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month. Accessed February 18, 2026. https://www.jnj.com/media-center/press-releases/fda-approves-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-as-the-only-egfr-targeted-therapy-that-can-be-administered-once-a-month
- Scott SC, Mourão Dias J, Liu B, et al. PALOMA-2: Subcutaneous amivantamab administered every 4 weeks plus lazertinib in first-line EGFR-mutated advanced NSCLC. Presented at IASLC 2025 WCLC. September 6-9, 2025; Barcelona, Spain.
