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Genomic Score Predicts Patients' Progression to Multiple Myeloma

  • On May 20, 2025, the FDA Oncologic Drugs Advisory Committee voted 6-2 to support DARZALEX FASPRO for treating adults with high-risk smoldering multiple myeloma in the U.S.
  • This vote followed submission of an FDA approval application in November 2024 based on the Phase 3 AQUILA study, a randomized trial comparing daratumumab monotherapy to active monitoring in HR-SMM patients.
  • Findings from the AQUILA study, presented at the 2024 ASH Annual Meeting and reported in a leading medical journal, indicate that initiating treatment earlier may delay or prevent the progression to active multiple myeloma in patients who have not previously received approved therapies.
  • DARZALEX FASPRO, already FDA-approved since 2020 for nine MM indications and used globally by over 618,000 patients, demonstrated a favorable benefit-risk profile despite risks of infusion-related reactions occurring in 37 percent of cases.
  • If approved, DARZALEX FASPRO would be the first treatment for HR-SMM, offering a potential new approach to delay MM progression and fits Johnson & Johnson’s vision of early diagnosis and disease interception.
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U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma

ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study

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cancernetwork.com broke the news in on Tuesday, May 20, 2025.
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