The Babak Lab shared a post on LinkedIn:
“First FDA-Approved Therapy for High-Risk Smoldering Multiple Myeloma
The FDA has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adults with high-risk smoldering multiple myeloma (HR-SMM) – marking the first-ever treatment approved for this precancerous condition.
Key Focus
This approval shifts the paradigm from “watch and wait” to early therapeutic intervention for HR-SMM – aiming to delay progression to active multiple myeloma.
Key Insights
- Daratumumab targets the CD38 antigen on plasma cells.
- The subcutaneous formulation (with hyaluronidase-fihj) improves convenience and tolerability.
- In the Phase 3 AQUILA trial, the treatment reduced the risk of disease progression or death by 51% vs. observation alone.
- At 5 years, only 29.7% of patients on therapy required first-line treatment for active myeloma (vs. 53.6% in the observation group)
Conclusion
Darzalex Faspro becomes the first and only approved therapy for patients with HR-SMM, offering a new window of opportunity to act before full disease onset.
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A link to the Full Article.”
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