India Pharma Outlook Team | Friday, 20 February 2026
Johnson & Johnson today announced that the U.S. Food and Drug Administration has approved a simplified monthly dosing schedule for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for patients with advanced lung cancer.
The new RYBREVANT FASPRO regimen, used in combination with oral LAZCLUZE (lazertinib), is for the first-line treatment of EGFR-mutated advanced non-small cell lung cancer (NSCLC).
The approval allows patients to switch to once-monthly dosing as early as Week 5. Clinical data show the monthly schedule delivers outcomes consistent with the previously approved bi-weekly subcutaneous regimen. The treatment continues to offer a major shift from traditional IV therapy, cutting administration time from hours to minutes and reducing administration-related reactions (ARRs) fivefold.
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“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 from the PALOMA-2 study showed a high objective response rate in previously untreated EGFR-mutated advanced NSCLC patients receiving monthly RYBREVANT FASPRO plus LAZCLUZE. Safety findings mirrored bi-weekly dosing, with ARRs reported at 12% versus 13%, significantly lower than the 66% seen with historical IV administration.
