J&J’s Rybrevant Faspro gains FDA approval for new dosing in NSCLC

This combination, used alongside Lazcluze (lazertinib), is indicated as a first-line treatment for NSCLC.

The therapy dosing provides clinical outcomes consistent with those of the earlier approved bi-weekly subcutaneous regimen.

This development comes after the previous FDA approval of Rybrevant Faspro, which reduced administration time and resulted in a fivefold reduction in administration-related reactions compared to intravenous delivery.

The updated schedule enables eligible patients to transition to monthly dosing as early as week five, simplifying care delivery and allowing for further optimisation of treatment administration.

Data from the PALOMA-2 study, presented at the 2025 World Conference on Lung Cancer, showed that monthly Rybrevant Faspro administered with Lazcluze achieved a high objective response rate in previously untreated patients with advanced EGFR-mutated NSCLC.

The study confirmed a significant decrease in administration-related reactions compared to historical intravenous use and similar rates to those seen with bi-weekly subcutaneous delivery.

The safety profile of monthly Rybrevant Faspro dosing remains comparable to the bi-weekly regimen. Most adverse events were linked to EGFR/MET inhibition.

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.”

In December 2025, J&J completed its acquisition of Halda Therapeutics, a clinical-stage biotechnology company, for $3.05bn in cash.

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