New Treatment Coming for High-Risk Smoldering Myeloma?

Pharma company Johnson & Johnson sent in an application to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for a new high-risk smoldering myeloma treatment approval. This new treatment is known as Darzalex Faspro (daratumumab and hyaluronidase-fihj) and is an injection that works by slowing the progression of abnormal myeloma cells. 

In smoldering myeloma, abnormal cells are detectable in the bone marrow, but patients often experience few or no symptoms. Traditionally, doctors have relied on monitoring without immediate treatment until the disease advances to multiple myeloma. However, recent studies are beginning to shift this “watch and wait” mentality, with an increased focus on early treatments that may slow or prevent disease progression. 

Approval of Darzalex Faspro would be a significant milestone in empowering high-risk smoldering patients with a proactive option to help manage their condition sooner.

“Daratumumab has changed the standard of care in multiple myeloma,” said Dr. Yusri Elsayed, Head of Oncology at Johnson & Johnson, “and with these submissions, it could become the first approved treatment for high-risk smoldering myeloma, potentially shifting the treatment paradigm.”

So, what makes daratumumab promising for smoldering myeloma? 

Data from the ongoing phase 3 AQUILA study (NCT03301220) support the use of subcutaneous (via injection) daratumumab in high-risk smoldering multiple myeloma. 

This trial is testing daratumumab’s ability to extend progression-free survival (PFS), the time a patient lives without signs of disease progression. In the trial, one group receives daratumumab injections regularly, while the other follows the traditional monitoring approach. 

Researchers are closely examining each group’s responses, how long it takes for patients to respond, the time to progression into multiple myeloma, safety, and quality of life. The latest data will be shared at the upcoming American Society of Hematology (ASH) Annual Meeting, and we at HealthTree will bring you all the insights. 

Stay Tuned for More Results at Upcoming ASH Conference

In summary, Johnson & Johnson’s regulatory submissions for daratumumab and hyaluronidase-fihj (Darzalex Faspro) could represent a turn in the treatment of high-risk smoldering myeloma. Traditionally, smoldering myeloma has been managed through watchful waiting, yet emerging therapies show promise in targeting myeloma cells before progression to multiple myeloma. 

If approved, Darzalex Faspro could offer high-risk patients a proactive option, potentially extending progression-free survival and delaying the onset of symptomatic disease. With final data from the AQUILA trial soon to be announced, the potential of daratumumab in benefitting people diagnosed with smoldering myeloma. 

Stay tuned as we plan to cover more on this topic next month as more is released at the American Society of Hematology (ASH) conference. 

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This new treatment option could open doors for patients like you, offering a proactive approach for high-risk smoldering myeloma. HealthTree is here to support you on your journey by helping you track labs, stay informed on treatment advances, and provide free resources to be your best self-advocate. Create your free HealthTree account to stay empowered, informed, and ready to access the latest in myeloma care.

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If you are interested in learning more about smoldering myeloma you can visit our comprehensive articles: 

• Precursor Conditions of Multiple Myeloma 
• When Does Smoldering Myeloma Become Active Myeloma? 
• Is Watch and Wait Obsolete for Smoldering Myeloma and MGUS? 
• Current Approaches for Smoldering Myeloma 

Sources: 

• Subcutaneous daratumumab (DARA SC) versus active monitoring in patients (pts) with high-risk smoldering multiple myeloma (SMM): Randomized, open-label, phase 3 AQUILA study.
• FDA, EMA Receive Applications for Subcutaneous Daratumumab in Myeloma