European Commission Approved Subcutaneous DARZALEX® (daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant Eligibility

Core Insights - Halozyme Therapeutics announced that Janssen-Cilag International NV received European Commission approval for an indication extension of DARZALEX® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients [1] - The approval allows newly diagnosed patients to receive daratumumab subcutaneously, avoiding lengthy intravenous infusions, thus enhancing patient experience [1] - This approval follows a previous indication extension for daratumumab-VRd in October 2024, based on the Phase 3 PERSEUS study results [1][2] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative drug delivery solutions, particularly with its ENHANZE® technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical companies, including Roche, Takeda, and Pfizer, among others [4] - Halozyme also develops drug-device combination products aimed at enhancing patient comfort and adherence, with two proprietary commercial products, Hylenex® and XYOSTED® [5]