FDA Approved DARZALEX Faspro® for Adult Patients with High-Risk Smoldering Multiple Myeloma

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]