Johnson & Johnson (J&J) has obtained approval from the US Food and Drug Administration (FDA) for a revised dosing schedule of Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), introducing a once-monthly administration option for patients with advanced, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Rybrevant Faspro is used in combination with Lazcluze (lazertinib) and is indicated as a first-line treatment for NSCLC. The newly approved monthly dosing schedule delivers clinical outcomes consistent with those previously observed under the bi-weekly subcutaneous regimen.
The approval follows an earlier FDA authorisation for Rybrevant Faspro that shortened administration time and led to a fivefold reduction in administration-related reactions when compared to intravenous delivery. With the updated schedule, eligible patients may transition to monthly dosing as early as week five. This adjustment is designed to simplify care delivery while enabling further optimisation of treatment administration.
Clinical findings supporting the revised schedule were drawn from the PALOMA-2 study. Data presented at the 2025 World Conference on Lung Cancer demonstrated that monthly Rybrevant Faspro, when administered alongside Lazcluze, achieved a high objective response rate in previously untreated patients with advanced EGFR-mutated NSCLC.
The PALOMA-2 study also confirmed a significant decrease in administration-related reactions relative to historical intravenous use, with rates comparable to those reported under the bi-weekly subcutaneous delivery regimen. In terms of tolerability, the safety profile of the once-monthly Rybrevant Faspro schedule remains comparable to that of the bi-weekly regimen. Most adverse events were associated with EGFR/MET inhibition.
Commenting on the approval, J&J US medical affairs vice-president Mahadi Baig said: “This latest milestone represents the culmination of our unwavering efforts and commitment to fundamentally redefine the way we treat patients with EGFR-mutated non-small cell lung cancer.
“Building on unmatched overall survival and regimens that support proactive side effect management, this once-monthly injection now delivers the simplest and fastest combination therapy for patients with EGFR-mutated non-small cell lung cancer.”
Separately, in December 2025, J&J completed its acquisition of Halda Therapeutics, a clinical-stage biotechnology company, for $3.05bn in cash.
