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.