Core Insights - Halozyme Therapeutics announced FDA approval for DARZALEX Faspro® as the first treatment for high-risk smoldering multiple myeloma (HR-SMM), allowing earlier intervention before progression to active multiple myeloma [1][2][3] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical companies, including Roche, Takeda, and Pfizer, among others [4] Market Context - In 2025, over 36,000 individuals are expected to be diagnosed with multiple myeloma in the U.S., with approximately 15% classified as smoldering [2] - About 50% of patients diagnosed with HR-SMM are likely to progress to active disease within two years, highlighting the need for effective early treatment options [2] Clinical Study - The FDA approval was based on the AQUILA study, the largest Phase 3 trial evaluating DARZALEX Faspro® against active monitoring in HR-SMM patients [3]

Core Insights - Halozyme Therapeutics announced the European Commission approval for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE® for treating high-risk smouldering multiple myeloma (SMM) [1][2] - This approval marks a significant advancement in early intervention strategies for multiple myeloma, addressing critical patient needs [2] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical firms, including Roche, Takeda, and Pfizer, among others [4] - Halozyme has two proprietary commercial products, Hylenex® and XYOSTED®, and is involved in ongoing product development with various partners [5] Clinical Study Insights - The EC approval is based on data from the Phase 3 AQUILA study, which compared the efficacy and safety of daratumumab SC monotherapy against active monitoring in high-risk SMM patients [3]