New FDA approval for J&J’s Darzalex Faspro in HR-SMM

The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (NYSE: JNJ) Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM).

J&J noted that Darzalex Faspro is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma. Darzalex is already a major earner for the company, generating $3.67 billion sales, up 22%, in third-quarter 2025. It also won approval for SMM from the European Commission in July this year.

The FDA approval is based on findings from the AQUILA study, which evaluated the efficacy and safety of Darzalex Faspro compared to active monitoring (or "Watch and Wait") in the largest Phase III trial in patients with HR-SMM. The AQUILA study demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with Darzalex Faspro reducing the risk of disease progression to active multiple myeloma or death by 51 percent compared to active monitoring, according to the International Myeloma Working Group (IMWG) diagnostic criteria for multiple myeloma.