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DARZALEX FASPRO® Is the First and only Treatment Approved by the U.S. FDA for Patients with High-Risk Smoldering Multiple Myeloma

  • DARZALEX FASPRO® is the first and only treatment approved by the U.S. FDA for patients with high-risk smoldering multiple myeloma .
  • The FDA's approval was based on findings from the AQUILA study, which showed a 51% reduction in disease progression risk for patients using DARZALEX FASPRO® compared to active monitoring.
  • Results indicated that DARZALEX FASPRO® significantly delayed disease progression, highlighting the importance of early intervention.
  • With this approval, patients with HR-SMM can access DARZALEX FASPRO® before progressing to active multiple myeloma, aiming to improve outcomes.
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The Berkshire EagleThe Berkshire Eagle
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DARZALEX FASPRO® is the first and only treatment approved by the U.S. FDA for patients with high-risk smoldering multiple myeloma

Phase 3 AQUILA study showed DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring

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cancernetwork.com broke the news in on Thursday, November 6, 2025.
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