FDA Approval Expands Access to Subcutaneous Amivantamab for Patients With EGFR-Mutated Advanced NSCLC
Danny Nguyen, MD, City of Hope, Orange County, California, discusses the recent FDA approval of a new, simplified once-monthly dose of subcutaneous amivantamab when administered in combination with lazertinib for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC).
This approval was based on results from the PALOMA-2 trial which demonstrated maintained efficacy with improved convenience for patients.
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.
