FDA Approves Monthly Dosing for J&J's Rybrevant Faspro in EGFR-Mutated Lung Cancer
The FDA has approved a new monthly dosing schedule for Johnson & Johnson's Rybrevant Faspro combined with Lazcluze for first-line treatment of advanced EGFR-mutated non-small cell lung cancer, allowing patients to transition to monthly dosing as early as week five.
The US Food and Drug Administration has approved a new monthly dosing schedule for the combination therapy Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) used alongside Lazcluze (lazertinib) as a first-line treatment for patients with advanced, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer. The therapy dosing provides clinical outcomes consistent with those of the earlier approved bi-weekly subcutaneous regimen.
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. 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.
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.
The subcutaneous formulation of Rybrevant plus Lazcluze was approved in the EU in April 2025 and in the United States in December 2025. Johnson & Johnson believes its new cancer drugs, Talvey, Tecvayli and Rybrevant plus Lazcluze, have the potential to deliver peak sales of $5 billion.
Johnson & Johnson's Oncology segment comprises around 27% of total revenues and 42% of its Innovative Medicine segment sales. Its oncology sales rose 20.9% on an operational basis in 2025, driven by strong market growth and share gains of key products such as Darzalex and prostate cancer drug, Erleada. Darzalex generated more than $14 billion in sales in 2025, rising 22% year over year.
Johnson & Johnson expects the momentum to continue and targets its oncology sales to reach $50 billion by 2030. In December 2025, Johnson & Johnson completed its acquisition of Halda Therapeutics, a clinical-stage biotechnology company, for $3.05bn in cash.