CHMP Issues Positive Opinion for Subcutaneous RYBREVANT®(amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Core Viewpoint - Halozyme Therapeutics announced that Janssen-Cilag International NV received a positive opinion from the CHMP for extending marketing authorization for a subcutaneous formulation of RYBREVANT® (amivantamab) in combination with LAZCLUZE® (lazertinib) for treating advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Product Development and Approval - The subcutaneous formulation of amivantamab, developed using Halozyme's ENHANZE drug delivery technology, was recommended for approval in Europe, highlighting a five-minute administration time and a five-fold reduction in infusion-related reactions [2][3] - The positive opinion from CHMP is supported by results from the Phase 3 PALOMA-3 study, which indicates the efficacy of the treatment [2][4] Group 2: Company Overview and Technology - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of injected drugs [6][7] - The company has licensed its ENHANZE® technology to several leading pharmaceutical companies, including Roche, Takeda, and Pfizer, and has impacted over one million patients globally [6][7]