J&J Prepares US, EU Submissions for SC Darzalex in Smoldering MM

In a significant stride for Johnson & Johnson, the pharmaceutical giant has made regulatory submissions in the United States and Europe for their drug, Darzalex (daratumumab), as a monotherapy for high-risk smouldering multiple myeloma (HR-SMM). HR-SMM is an early stage of multiple myeloma (MM) where abnormal cells are present in the bone marrow but patients typically do not exhibit symptoms. Currently, the standard approach for managing HR-SMM involves active monitoring without immediate treatment. However, Johnson & Johnson believes that Darzalex has the potential to prevent or significantly delay the progression to full-blown MM.

Supporting this optimistic outlook are the results from the Phase III AQUILA study, which were recently shared in an abstract ahead of the American Society of Hematology’s (ASH) upcoming meeting in December. The study's data indicate a positive impact of Darzalex on patients with HR-SMM. As of the data cut-off point, the median progression-free survival (PFS) and the median time to first-line treatment had not been reached in the group treated with Darzalex. In contrast, patients under active monitoring showed a median PFS of 41.5 months and a median time to first treatment of 50.2 months.

Yusri Elsayed, the global therapeutic area head of oncology and innovative medicine at Johnson & Johnson, emphasized the critical need for early interventions and treatments that are both effective and well-tolerated in patients with HR-SMM. He highlighted that Darzalex has already transformed the treatment landscape for multiple myeloma. With the new regulatory submissions to the FDA and EMA, Darzalex could become the first approved treatment specifically for HR-SMM, potentially revolutionizing how this early precursor to multiple myeloma is managed.

The pharmaceutical company is moving forward with confidence, buoyed by the three-year results from the AQUILA study, which reinforce their proposal that Darzalex can offer a significant benefit in delaying the progression of HR-SMM to multiple myeloma. This data is particularly crucial as it shows that Darzalex-treated patients have not yet reached their median time to first-line treatment, suggesting a prolonged period before the disease progresses to a more severe state requiring further intervention.

In summary, Johnson & Johnson’s recent regulatory submissions for Darzalex represent a potential major advancement in the treatment of high-risk smouldering multiple myeloma. The company’s efforts are supported by encouraging data from the AQUILA study, which suggests that Darzalex could offer a significant delay in disease progression. If approved, this treatment could set a new standard of care for patients with HR-SMM, addressing an unmet need for early, effective, and well-tolerated interventions.