The U.S. Food and Drug Administration has approved a simpler once-monthly (every 4 weeks) dosing schedule for Rybrevant Faspro (subcutaneous amivantamab with hyaluronidase) combined with lazertinib as first-line treatment for advanced EGFR-mutated non-small cell lung cancer (NSCLC). Patients can switch to the monthly schedule as early as Week 5, reducing the need for frequent clinic visits compared with the previous weekly or biweekly dosing.
The approval is based on results from the PALOMA-2 study. The trial showed that monthly subcutaneous injections provided the same effectiveness and safety as more frequent dosing or intravenous (IV) treatment. The overall response rate was 82% by investigators and 87% by independent review. The median time to response was 8.1 weeks. At 6.5 months of follow-up, the median duration of response and overall survival had not yet been reached, suggesting durable benefit.
The new formulation also improved tolerability and convenience. Administration-related reactions dropped to 12% with the subcutaneous injection, compared with 66% for IV treatment. When anticoagulation was used, venous thromboembolic events occurred in 13% of patients, lower than the historical 38% seen with IV amivantamab without anticoagulation. Drug levels in the blood were comparable to earlier dosing schedules, confirming maintained potency. Overall, the once-monthly injection offers a more convenient option that may improve patient adherence and quality of life.