DARZALEX Faspro®: New Approval in High-Risk Myeloma!

Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced on November 7, 2025, that Johnson & Johnson has received new approval from the U.S. Food and Drug Administration (FDA) for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of high-risk smoldering multiple myeloma (HR-SMM). DARZALEX Faspro® is the first and only treatment approved for HR-SMM, allowing intervention before the disease progresses to active multiple myeloma.

Halozyme's CEO, Dr. Helen Torley, stated, “DARZALEX Faspro is the first treatment approved in the U.S. for adult patients with high-risk smoldering multiple myeloma.” She added, “This approval further solidifies DARZALEX Faspro’s essential treatment role across all stages of multiple myeloma by expanding its use with ENHANZE.”

Smoldering multiple myeloma (SMM) is an asymptomatic malignancy and is genomically identical to active multiple myeloma; these abnormal cells can be detected in the bone marrow. In 2025, it is expected that over 36,000 people in the United States will be diagnosed with multiple myeloma, with approximately 15% being classified as smoldering. Patients diagnosed with HR-SMM have a 50% chance of progressing to active disease within two years of diagnosis. Current standard care includes active surveillance to monitor for signs of biochemical progression and/or organ damage. Recent data suggests that early intervention in patients at high risk of progression to active multiple myeloma may be beneficial.

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

Halozyme is a biopharmaceutical company that develops groundbreaking solutions to improve patient experiences and outcomes through its innovative ENHANZE® drug delivery technology. The ENHANZE® technology is utilized to facilitate the subcutaneous delivery of injected medications and fluids. Halozyme has effectively served over one million patients and has licensed its technology to leading pharmaceutical companies worldwide, including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, and others.

The company is headquartered in San Diego, California, with offices in Ewing, New Jersey, and Minnetonka, Minnesota.