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U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer
Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).1 RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) and represents the
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[{"type":"text","content":"RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw)","length":85,"tagName":"p","attribs":{}},{"type":"text","content":"SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).1 RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) and represents the first and only subcutaneously (SC) administered targeted therapy for patients with EGFR+ mNSCLC.","length":641,"tagName":"p"},{"type":"text","content":"Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ significantly reduced administration time from several hours to approximately five minutes and demonstrated an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm).","length":287,"tagName":"p"},{"type":"text","content":""Formulated with our leading ENHANZE drug delivery technology, RYBREVANT FASPRO™ has the potential to make administration faster and more convenient for patients and their families compared to intravenous administration," said Dr. Helen Torley, president and chief executive officer of Halozyme. "By reducing administration times and simplifying the treatment experience, ENHANZE-formulated products could also support efficiencies for healthcare providers and lower costs for the healthcare system. This approval underscores ENHANZE's role in delivering meaningful clinical and economical value for patients, providers and payers."","length":656,"tagName":"p"},{"type":"text","content":"Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].1,2","length":318,"tagName":"p"},{"type":"text","content":"For more information on this approval, please view Johnson & Johnson's press releas...