Healthcare giant Johnson & Johnson has announced that the US FDA has approved a simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in patients with advanced lung cancer.
When combined with oral LAZCLUZE (lazertinib) for first-line treatment of EGFR-mutated advanced non-small cell lung cancer (NSCLC), the monthly regimen delivers outcomes consistent with the previously approved bi-weekly subcutaneous dosing schedule.
This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care—cutting administration time from hours to minutes and reducing administration-related reactions (ARRs) fivefold compared to traditional IV delivery. Patients can transition to the new monthly dosing as early as Week 5, offering greater convenience without compromising efficacy.
“A monthly dosing schedule offers patients convenience without sacrificing efficacy,” said Danny Nguyen, 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.”
Data presented at the 2025 World Conference on Lung Cancer (WCLC) from the PALOMA-2 study showed that monthly RYBREVANT FASPRO plus LAZCLUZE produced a high objective response rate in previously untreated EGFR-mutated advanced NSCLC. The study also confirmed a significant reduction in ARRs compared with IV administration, maintaining consistency with bi-weekly subcutaneous dosing.
“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,” said Mahadi Baig, Vice President, U.S. Medical Affairs, Johnson & Johnson.
“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.”
Safety data showed monthly dosing mirrors bi-weekly administration. Most adverse events were related to EGFR/MET inhibition, with ARRs consistent at 12% versus 13% for bi-weekly dosing, and fivefold lower than historical IV administration at 66%. Venous thromboembolic events were similarly comparable or lower than prior IV data.
