Johnson & Johnson has won FDA approval for a simplified, once-monthly subcutaneous dosing schedule for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) when used in combination with oral Lazcluze (lazertinib) for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations.
Under the new regimen, patients receive weekly subcutaneous injections for the first four weeks and can then transition to monthly (every-4-weeks) maintenance dosing as early as week 5. J&J said the monthly schedule delivers outcomes and pharmacokinetics comparable to the previously approved bi-weekly subcutaneous dosing.
The approval builds on the December 2025 FDA clearance of subcutaneous Rybrevant Faspro across all indications of intravenous Rybrevant, which cut administration time from hours to minutes and reduced administration-related reactions relative to intravenous delivery. Supporting data came from the PALOMA program, including the PALOMA-2 and PALOMA-3 trials.