Today, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for amivantamab and hyaluronidase-lpuj (Rybrevant Faspro). When administered in combination with oral lazertinib for the first-line treatment EGFR-mutated advanced non–small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes when compared to the previously approved biweekly subcutaneous dosing schedule.
The once-monthly dosing begins from week 5 of treatment onward; weekly injections need to be administered from weeks 1 to 4.
This approval builds upon the December 2025 FDA approval of the subcutaneous injection of amivantamab and hyaluronidase-lpuj, which reduced administration time from hours to minutes and resulted in a fivefold reduction in administration-related reactions when compared to intravenous (IV) delivery. With the new dosing schedule, patients are able to transition to monthly dosing as early as week 5 of treatment. Together, these advances build on a survival benefit while supporting continued treatment optimization, further simplifying care delivery and offering greater convenience.
“A monthly dosing schedule offers patients convenience without sacrificing efficacy,” said Danny Nguyen, MD, Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, City of Hope, and principal investigator for the PALOMA-3 and MARIPOSA studies. “With a flexible schedule that reduces time in the clinic, patients may be able to stay on therapy longer and free up time to focus on the moments that matter most.”
Recently presented at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer, PALOMA-2 data demonstrated that monthly amivantamab and hyaluronidase-lpuj dosing in combination with lazertinib delivered a high objective response rate in previously untreated patients with EGFR-mutated advanced NSCLC (Abstract MA08.05). The study showed significant reduction in administration-related reactions compared to historical IV administration and consistent rates with biweekly subcutaneous delivery.
The safety profile of monthly dosing of amivantamab and hyaluronidase-lpuj is comparable to when it is administered every 2 weeks. Consistent with IV and subcutaneous administration, most adverse events were related to EGFR/MET inhibition. Administration-related reactions were consistent with the biweekly dosing schedule (12% vs 13% respectively) and fivefold lower when compared to historical IV administration (66%). Similarly, venous thromboembolic events were consistent with biweekly subcutaenous administration (13% vs 11% with anticoagulation) and lower than historical IV data without anticoagulation (38%).
No new safety signals were identified. Only 8% of patients discontinued amivantamab due to treatment-related adverse events. The mean plasma concentration levels were consistent with historical IV and bi-weekly subcutaneous dosing data, supporting pharmacokinetic comparability.
