Johnson & Johnson's DARZALEX FASPRO®: First FDA-Approved Treatment for High-Risk Smoldering Multiple Myeloma

FDA Approval

The U.S. FDA has approved DARZALEX FASPRO® as a treatment for high-risk smoldering multiple myeloma (HR-SMM). This marks the first approved treatment for HR-SMM, allowing for earlier intervention before the disease progresses to active multiple myeloma.

AQUILA Study Findings

The approval is based on the Phase 3 AQUILA study, which demonstrated that DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51% compared to active monitoring. The study had a median follow-up of 65.2 months, with 63.1% of patients not progressing to active myeloma at five years.

Study Details

The AQUILA study was the largest Phase 3 trial for HR-SMM, comparing DARZALEX FASPRO® to active monitoring. The primary endpoint was progression-free survival (PFS), with DARZALEX FASPRO® showing a significant improvement. The study also reported a higher response rate of 63.4% for patients receiving DARZALEX FASPRO® compared to 2.0% with active monitoring.

Adverse Reactions

Adverse reactions in the AQUILA study were consistent with previous studies of DARZALEX FASPRO®. Common reactions included upper respiratory tract infection, musculoskeletal pain, fatigue, and injection site reactions. Serious infections occurred in 24% of patients, with pneumonia being the most common.

Implications

This approval supports a shift in treatment strategy for HR-SMM, emphasizing earlier intervention. DARZALEX FASPRO® is a combination of daratumumab and hyaluronidase-fihj, and it is the only subcutaneous CD38-directed antibody approved for multiple myeloma treatment.