Johnson & Johnson's New FDA Approval Lets Lung Cancer Patients Switch To Monthly Dosing Sooner
The U.S. Food and Drug Administration (FDA) on Tuesday approved a new, simplified monthly dosing schedule for Johnson & Johnson’s (NYSE:JNJ) Rybrevant Faspro (amivantamab and hyaluronidase-lpuj).
When administered in combination with oral Lazcluze (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule.
The 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 (ARRs) when compared to intravenous (IV) delivery.
In December 2025, the FDA approved Rybrevant Faspro as the first and only subcutaneously (SC) administered therapy for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
Rybrevant Faspro is approved for all indications for which Rybrevant is approved.
With this newly approved monthly dosing schedule, patients are able to transition to monthly dosing as early as Week.
“A monthly dosing schedule offers patients convenience without sacrificing efficacy,” said Danny Nguyen, principal investigator for the PALOMA-3 and MARIPOSA studies.
Recently presented at the 2025 World Conference on Lung Cancer (WCLC), PALOMA-2 data demonstrated that monthly Rybrevant Faspro dosing in combination with Lazcluze delivered a high objective response rate (ORR) in previously untreated, EGFR-mutated advanced NSCLC.
The study showed a significant reduction in ARRs compared to historical IV administration and consistent rates with bi-weekly SC delivery.
JNJ Price Action: Johnson & Johnson shares were down 0.35% at $242.59 at the time of publication on Tuesday. The stock is trading near its 52-week high of $246.34.
Photo by Komsan Loonprom via Shutterstock
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