Johnson & Johnson Seeks Approval for Darzalex Faspro in the U.S. and Darzalex in the EU for Myeloma Treatment

Key Insights

• Johnson & Johnson has submitted regulatory applications to the FDA for Darzalex Faspro and to the EMA for Darzalex, targeting myeloma treatment.
• The applications are based on Phase 3 AQUILA study data, evaluating Darzalex Faspro as a monotherapy for high-risk smoldering multiple myeloma.
• If approved, Darzalex Faspro would be the first treatment option specifically for patients with high-risk smoldering multiple myeloma, addressing a critical unmet need.

Johnson & Johnson has announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) for Darzalex Faspro and to the European Medicines Agency (EMA) for Darzalex, seeking approval for the treatment of myeloma. These submissions are based on data from the ongoing Phase 3 AQUILA study, which is evaluating Darzalex Faspro as a monotherapy for adult patients diagnosed with high-risk smoldering multiple myeloma, an early precursor to active multiple myeloma.

The AQUILA study is a significant trial assessing the efficacy and safety of Darzalex Faspro in patients with high-risk smoldering multiple myeloma. Smoldering multiple myeloma represents an intermediate stage between monoclonal gammopathy of undetermined significance (MGUS) and active multiple myeloma. Patients with high-risk smoldering myeloma have a significantly increased likelihood of progressing to active disease, which necessitates more aggressive treatment approaches.

Potential Impact of Darzalex Faspro

If approved, Darzalex Faspro would represent a significant advancement in the treatment paradigm for multiple myeloma. It would become the first approved therapeutic option specifically indicated for patients with high-risk smoldering multiple myeloma. This approval could potentially delay or prevent the progression to active multiple myeloma, thereby improving patient outcomes and quality of life. The current treatment landscape for smoldering myeloma often involves a watchful waiting approach until the disease progresses to active myeloma, highlighting the unmet need for effective interventions during the earlier smoldering stage.

Darzalex (daratumumab) is a CD38-directed monoclonal antibody. Darzalex Faspro is a subcutaneous formulation of daratumumab. The AQUILA study explores its use as a monotherapy in the specified patient population. The study's primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), time to progression to active multiple myeloma, and safety. The specific dosing regimen and administration route for Darzalex Faspro were detailed in the application to regulatory agencies.