FDA Approves J&J's Darzalex for Smoldering Multiple Myeloma, Marking Industry First

In a groundbreaking development for the pharmaceutical industry, Johnson & Johnson's Darzalex Faspro has received FDA approval for the treatment of high-risk smoldering multiple myeloma (SMM), becoming the first therapy approved for this indication. This expansion of Darzalex Faspro's label represents a significant shift in the management of multiple myeloma, allowing for earlier intervention in the disease progression.

Darzalex Faspro's Breakthrough in SMM Treatment

The FDA's decision is based on compelling data from the Phase III AQUILA study, which demonstrated Darzalex Faspro's ability to significantly delay disease progression to active multiple myeloma. The study, involving nearly 400 patients, showed a 51% overall benefit in delaying progression compared to active monitoring, with an even more pronounced 64% benefit in high-risk patients.

Dr. Neil Vasan, an assistant professor at Columbia University Medical Center, noted the strong efficacy data, although he also highlighted concerns about toxicity during the FDA advisory committee meeting.

Clinical Impact and Patient Benefits

This approval marks a paradigm shift in the treatment of multiple myeloma, offering a proactive approach to managing SMM. Previously, physicians could only monitor patients with SMM, hoping to catch early signs of progression to active multiple myeloma. Now, with Darzalex Faspro, there is an opportunity for earlier disease interception.

According to J&J, approximately 15% of new myeloma diagnoses are classified as SMM, with about 50% of high-risk SMM cases likely to progress to active multiple myeloma within two to three years. The AQUILA study results showed that Darzalex Faspro not only delayed disease progression but also improved overall survival by 48%.

Market Implications and Financial Performance

Darzalex Faspro has rapidly become one of J&J's most valuable franchises since its initial FDA approval in 2020. In 2024, the product generated more than $11.6 billion in worldwide sales, accounting for over half of J&J's cancer earnings. The third quarter of 2025 saw Darzalex Faspro emerge as J&J's top-selling drug, with sales exceeding $3.6 billion, representing nearly 20% year-on-year growth.

This latest approval is expected to further solidify Darzalex Faspro's market position and potentially expand its already substantial revenue stream. The drug's success also reflects the growing importance of targeted therapies in oncology, particularly those that can intervene earlier in the disease course.