Health
U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when Combined with LAZCLUZE® (lazertinib)
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).1 RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw).
About this update from Johnson & Johnson
[{"type":"text","content":"RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions1-5","length":208,"tagName":"p"},{"type":"text","content":"Approval builds on previously reported Phase 3 MARIPOSA data showing unmatched overall survival benefit of this chemotherapy-free regimen, projected to exceed four years6 ","length":170,"tagName":"p"},{"type":"text","content":"HORSHAM, Pa., Dec. 17, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).1 RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw).","length":457,"tagName":"p"},{"type":"text","content":"Experience the full interactive Multichannel News Release here: https://www.multivu.com/johnson-and-johnson/9361151-en-johnson-and-johnson-us-fda-approval-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj","length":206,"tagName":"p"},{"type":"text","content":"Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ offers significantly higher patient convenience and lower burden on healthcare resources1-5:","length":149,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Reducing administration time from several hours to five minutes (significantly less administration time than chemotherapy-based regimens, which could take up to an hour);","length":170,"tagName":"p"}]},{"val":[{"type":"text","content":"Demonstrating an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm); and","length":140,"tagName":"p"}]},{"val":[{"type":"text","content":"Reducing venous thromboembolism (VTE) incidence (11 percent in SC vs 18 percent in IV arm).","length":91,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":401,"olType":false},{"type":"text","content":"Multimedia assets for media are available here.","length":52,"tagName":"p"},{"type":"text","content":"Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consisten...