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

Core Viewpoint - Halozyme Therapeutics announced that Johnson & Johnson received FDA approval for RYBREVANT FASPRO™, a subcutaneously administered targeted therapy for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) [1][4]. Group 1: Product Approval and Benefits - RYBREVANT FASPRO™ is the first and only subcutaneously administered therapy for EGFR+ mNSCLC, approved across all indications of RYBREVANT® [1]. - Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ significantly reduced administration time from several hours to approximately five minutes and demonstrated a fivefold reduction in administration-related reactions (ARRs) (13% in SC vs 66% in IV) [2]. - The approval highlights the role of ENHANZE technology in providing clinical and economic value for patients, healthcare providers, and payers [3]. Group 2: Clinical Study Results - RYBREVANT FASPRO™ met both co-primary pharmacokinetic (PK) endpoints in the Phase 3 PALOMA-3 study, demonstrating consistent results with RYBREVANT® [4]. Group 3: Company Overview and Technology - Halozyme is a biopharmaceutical company focused on improving patient experiences through innovative drug delivery solutions, particularly with its ENHANZE technology [6]. - The company is also developing Hypercon™, a microparticle technology aimed at enhancing drug concentration and reducing injection volume, which broadens the scope of therapeutics for subcutaneous delivery [7]. - Halozyme has commercialized ten products using ENHANZE technology, impacting over one million patients globally [6].