Johnson & Johnson’s Rybrevant Faspro regimen approved by FDA for NSCLC

Johnson & Johnson announced the FDA has approved a new, simplified monthly dosing schedule for Rybrevant Faspro – amivantamab and hyaluronidase-lpuj -. When administered in combination with oral Lazcluze – lazertinib – for the first-line treatment of epidermal growth factor receptor, or EGFR,-mutated advanced non-small cell lung cancer, or NSCLC, monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous dosing schedule. This milestone builds upon the recent FDA approval of Rybrevant Faspro, which transformed administration time from hours to minutes and offers a fivefold reduction in administration-related reactions, or ARRs, when compared to intravenous delivery. With this newly approved monthly dosing schedule, patients are able to transition to monthly dosing as early as Week 5. PALOMA-2 data demonstrated that monthly Rybrevant Faspro dosing in combination with Lazcluze delivered a high objective response rate, or, in previously untreated, EGFR-mutated advanced NSCLC. The study showed significant reduction in ARRs compared to historical IV administration and consistent rates with bi-weekly SC delivery. The safety profile of monthly dosing of Rybrevant Faspro is comparable when it is administered every two weeks. No new safety signals were identified.