Accessibility StatementSkip Navigation DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology SAN DIEGO, Nov. 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR- ...

Core Viewpoint - Regeneron and Johnson & Johnson face challenges in the early intervention field for smoldering multiple myeloma (SMM), despite promising new data. The adoption of Regeneron's Lynozyfic and Johnson's Darzalex may be slow due to the need for physicians to balance the risks of overtreatment with the difficulty in identifying high-risk patients who may benefit [3][4]. Group 1: Regeneron's Lynozyfic - Lynozyfic shows a total response rate (ORR) of 100% and a complete response rate (CR) of 36.8% for high-risk SMM, but these rates may not be as significant for active myeloma. The key measure of success is whether the drug can delay disease progression and improve survival [4][5]. - The safety profile of Lynozyfic raises concerns, with a 12.5% incidence of grade 3-4 infections and a 25% incidence of grade 3-4 neutropenia, alongside a 42% occurrence of any grade cytokine release syndrome [4][5]. Group 2: Johnson & Johnson's Darzalex - The AQUILA trial indicates that Darzalex monotherapy extends progression-free survival (PFS) and overall survival (OS) for high-risk SMM patients, reducing disease progression rates from 41.8% in the observation group to 21.8%. This has led to EU approval and potential FDA approval [8]. - There are concerns regarding the definition of "high-risk" SMM in the AQUILA trial compared to existing SLiM standards, which may hinder the widespread application of Darzalex due to the asymptomatic nature of the disease [8]. Group 3: Patient Identification and Treatment Concerns - The Quiredex trial shows that lenalidomide combined with dexamethasone significantly delays the progression to multiple myeloma, with a PFS of 9.5 years compared to 2.1 years for the control group. However, many physicians remain cautious about early intervention due to overtreatment risks and challenges in accurately identifying high-risk patients [6][8]. - The use of circulating tumor DNA (ctDNA) detection technology is suggested to better identify patients at high risk of progressing to multiple myeloma, aiming to minimize overtreatment [6].