EC Approves J&J's Darzalex for High-Risk SMM Treatment

Johnson & Johnson (J&J) recently received approval from the European Commission (EC) for its antibody drug, Darzalex (daratumumab), specifically targeting CD38. This new approval marks a significant advancement as it authorizes the subcutaneous form of Darzalex as a standalone treatment for adults with smouldering multiple myeloma (SMM). SMM is considered an early stage of the blood cancer known as multiple myeloma (MM), and this approval identifies high-risk SMM patients as potential beneficiaries of early intervention, aiming to prevent the progression to active MM.

In 2022, MM was diagnosed in over 35,000 individuals across Europe. SMM represents about 15% of these new cases, and patients are typically not treated until the disease progresses to active MM. However, emerging research indicates that early treatment in high-risk SMM patients can potentially delay the onset of more severe stages of the disease. Darzalex, already approved in the EU for various MM-related conditions and AL amyloidosis, functions by targeting the CD38 protein found abundantly on MM cancer cells, thereby inhibiting tumor growth.

The European Commission’s decision to approve Darzalex for SMM patients derives from promising results of the phase 3 AQUILA trial. This study involved 390 high-risk SMM patients and compared the effects of Darzalex with active monitoring. The trial's findings revealed that patients receiving Darzalex had a significant improvement in progression-free survival (PFS) compared to those under standard monitoring practices. Specifically, for patients retrospectively classified as high-risk SMM, the median PFS was not reached in the group treated with Darzalex, while it stood at 22.1 months for those monitored actively.

Furthermore, Darzalex SC, which is enhanced with Halozyme’s ENHANZE drug delivery technology, showed a notable extension in overall survival rates. The five-year survival rate was 93% for the Darzalex group, compared to 86.9% for those in the active monitoring group. In addition, patients treated with Darzalex demonstrated a higher overall response rate, suggesting a more effective treatment outcome.

Jordan Schecter, Vice President and Disease Area Leader for MM at J&J's Innovative Medicine division, emphasized the significance of this approval. With the availability of Darzalex for all stages of the disease, physicians and patients are now presented with the opportunity to initiate treatment during the SMM phase, potentially delaying disease progression and reducing the necessity for more intensive treatments later on. This approach not only aims to extend overall survival but also improves the quality of life for patients by managing the disease more effectively from an earlier stage.

In summary, the EC's approval of Darzalex as a monotherapy for high-risk SMM patients represents a pivotal development in the treatment of multiple myeloma. It underscores the potential benefits of early intervention in preventing the transition from SMM to active MM, thereby offering hope for better management and improved outcomes for patients facing this challenging disease.