FDA

FDA OKs monthly dosing for Rybrevant Faspro for EGFR-mutated NSCLC

February 20, 2026

On February, 17, 2026, FDA approved a monthly dosing schedule for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

When paired with oral lazertinib as a first-line therapy for EGFR‑mutated advanced NSCLC, the new once‑monthly regimen provides outcomes consistent with those achieved using the previously approved bi‑weekly SC dosing schedule.

Efficacy

Approval of the new dosing regimen was based on data from the PALOMA-2 trial (NCT05498428), which showed that monthly Rybrevant Faspro dosing in combination with lazertinib resulted in a high objective response rate in previously untreated, EGFR-mutated advanced NSCLC. The study showed significant reduction in administration-related reactions (ARRs) compared with historical IV administration and consistent rates with bi-weekly SC delivery.

Mean plasma concentrations were consistent with historical IV and bi-weekly SC dosing data, supporting pharmacokinetic comparability.

Safety

The safety profile of monthly dosing of Rybrevant Faspro is comparable to that of bi-weekly dosing. Consistent with IV and SC administration, most adverse events were related to EGFR/MET inhibition. ARRs were consistent with the bi-weekly dosing schedule (12% vs. 13%, respectively) and fivefold lower when compared with historical IV administration (66%). Similarly, venous thromboembolic events (VTEs) were consistent with bi-weekly SC administration (13% vs. 11% with anticoagulation) and lower than historic IV data without anticoagulation (38%). No new safety signals were identified.

Sources:

FDA approves Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month. [News release]. 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

Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) [package insert]. Johnson & Johnson. https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT+Faspro-pi.pdf Revised February 2026. Accessed February 19, 2026.