Halozyme Therapeutics announced that Johnson & Johnson received US 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-SMM). DARZALEX Faspro is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma.

"DARZALEX Faspro is the first approved treatment in the US for adult patients with High Risk Smoldering Multiple Myeloma. The approval expands the indications for DARZALEX Faspro with ENHANZE, further solidifying its role as a cornerstone therapy across all stages of multiple myeloma," said Dr Helen Torley, President and CEO, Halozyme.

Smoldering Multiple Myeloma (SMM) is an asymptomatic malignancy that is genomically the same as active multiple myeloma and where these abnormal cells can be detected in the bone marrow. In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the US, and approximately 15 percent of those are classified as smoldering.

An estimated 50 percent of patients diagnosed with HR-SMM are likely to progress to active disease within two years of diagnosis. Currently, the standard of care for HR-SMM is active monitoring to track signs of biochemical progression and/or end-organ damage. Recent evidence suggests that people at high-risk of progressing to active multiple myeloma could benefit from earlier therapeutic intervention.

The FDA approval is based on findings from the AQUILA study (NCT03301220), which evaluated the efficacy and safety of DARZALEX Faspro compared to active monitoring (or Watch and Wait) in the largest Phase 3 trial in patients with HR-SMM.