FDA Approves DARZALEX Faspro® for High-Risk Smoldering Multiple Myeloma Patients
On November 7, 2025, in a groundbreaking announcement, Halozyme Therapeutics revealed that Johnson & Johnson has obtained approval from the U.S. Food and Drug Administration (FDA) for the drug DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) as a treatment for adult patients diagnosed with high-risk smoldering multiple myeloma (HR-SMM). This marks a significant step in the treatment landscape as DARZALEX Faspro® becomes the first and only FDA-approved option for this category of patients.
Smoldering multiple myeloma (SMM) is a precursor stage to active multiple myeloma and is characterized by the presence of malignant plasma cells in the bone marrow, often remaining asymptomatic. Current estimates suggest that over 36,000 individuals will be diagnosed with multiple myeloma in the U.S. in 2025, with approximately 15% of those cases classified as smoldering. Alarmingly, around 50% of patients with HR-SMM may progress to active disease within just two years of their initial diagnosis.
Historically, medical professionals have monitored patients with HR-SMM with the expectation that they will transition to active disease, at which point more aggressive intervention may begin. However, emerging evidence suggests that early therapeutic intervention may benefit those at high risk of progressing to active multiple myeloma. Therefore, the approval of DARZALEX Faspro® is anticipated to shift treatment protocols, allowing for intervention before the disease escalates.
"DARZALEX Faspro is now recognized as the first approved treatment in the U.S. specifically for adult patients with high-risk smoldering multiple myeloma," stated Dr. Helen Torley, President and CEO of Halozyme. This new indication supports the notion that DARZALEX Faspro, along with the proprietary ENHANZE® drug delivery technology, can play an integral role across all stages of multiple myeloma treatment.
The FDA's decision is rooted in the findings from the AQUILA study, which was the largest Phase 3 clinical trial focusing on HR-SMM patients. This comprehensive research evaluated the efficacy and safety of DARZALEX Faspro® in comparison to conventional active monitoring, further corroborating the importance of proactive treatment in at-risk populations. The outcomes from this pivotal study illustrate the drug’s potential in reducing the rate of progression to more severe stages of multiple myeloma.
Halozyme Therapeutics is renowned for its innovative approach to drug delivery, with its ENHANZE® technology enabling faster and more efficient administration of therapeutic agents. The approval of DARZALEX Faspro® exemplifies Halozyme's commitment to enhancing patient experiences, aiming to reduce the burden associated with treatment while also improving overall health outcomes.
In practical terms, this means that patients previously designated for 'watchful waiting' will now have access to a therapeutic agent designed specifically for their condition, fostering earlier intervention. The expectation is that initiating treatment sooner could significantly alter the trajectory of the disease, providing hope for better management and improved patient outcomes.
Given that the FDA approval comes at a time when the multiple myeloma community is looking for advancements in treatment options, DARZALEX Faspro® positions itself as a front-runner in the next generation of cancer therapies. With ongoing studies and the growing body of evidence supporting its use, the drug symbolizes an important milestone in the voyage toward more effective and compassionate cancer care.
Patients and healthcare providers alike are encouraged to view this development as a beacon of hope, paving the way for more innovative treatment solutions in the realm of hematological malignancies. As research continues to evolve in this field, the possibilities for improving patient lives become increasingly promising. For further information regarding DARZALEX Faspro® and its implications in the treatment of high-risk smoldering multiple myeloma, stakeholders can consult the official press release from Johnson & Johnson issued on November 6, 2025.
Smoldering multiple myeloma (SMM) is a precursor stage to active multiple myeloma and is characterized by the presence of malignant plasma cells in the bone marrow, often remaining asymptomatic. Current estimates suggest that over 36,000 individuals will be diagnosed with multiple myeloma in the U.S. in 2025, with approximately 15% of those cases classified as smoldering. Alarmingly, around 50% of patients with HR-SMM may progress to active disease within just two years of their initial diagnosis.
Historically, medical professionals have monitored patients with HR-SMM with the expectation that they will transition to active disease, at which point more aggressive intervention may begin. However, emerging evidence suggests that early therapeutic intervention may benefit those at high risk of progressing to active multiple myeloma. Therefore, the approval of DARZALEX Faspro® is anticipated to shift treatment protocols, allowing for intervention before the disease escalates.
"DARZALEX Faspro is now recognized as the first approved treatment in the U.S. specifically for adult patients with high-risk smoldering multiple myeloma," stated Dr. Helen Torley, President and CEO of Halozyme. This new indication supports the notion that DARZALEX Faspro, along with the proprietary ENHANZE® drug delivery technology, can play an integral role across all stages of multiple myeloma treatment.
The FDA's decision is rooted in the findings from the AQUILA study, which was the largest Phase 3 clinical trial focusing on HR-SMM patients. This comprehensive research evaluated the efficacy and safety of DARZALEX Faspro® in comparison to conventional active monitoring, further corroborating the importance of proactive treatment in at-risk populations. The outcomes from this pivotal study illustrate the drug’s potential in reducing the rate of progression to more severe stages of multiple myeloma.
Halozyme Therapeutics is renowned for its innovative approach to drug delivery, with its ENHANZE® technology enabling faster and more efficient administration of therapeutic agents. The approval of DARZALEX Faspro® exemplifies Halozyme's commitment to enhancing patient experiences, aiming to reduce the burden associated with treatment while also improving overall health outcomes.
In practical terms, this means that patients previously designated for 'watchful waiting' will now have access to a therapeutic agent designed specifically for their condition, fostering earlier intervention. The expectation is that initiating treatment sooner could significantly alter the trajectory of the disease, providing hope for better management and improved patient outcomes.
Given that the FDA approval comes at a time when the multiple myeloma community is looking for advancements in treatment options, DARZALEX Faspro® positions itself as a front-runner in the next generation of cancer therapies. With ongoing studies and the growing body of evidence supporting its use, the drug symbolizes an important milestone in the voyage toward more effective and compassionate cancer care.
Patients and healthcare providers alike are encouraged to view this development as a beacon of hope, paving the way for more innovative treatment solutions in the realm of hematological malignancies. As research continues to evolve in this field, the possibilities for improving patient lives become increasingly promising. For further information regarding DARZALEX Faspro® and its implications in the treatment of high-risk smoldering multiple myeloma, stakeholders can consult the official press release from Johnson & Johnson issued on November 6, 2025.
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