FDA Approves Johnson & Johnson's Darzalex Faspro for Early Myeloma Intervention
The Food and Drug Administration (FDA) has approved Johnson & Johnson's (NYSE: JNJ) Darzalex Faspro (daratumumab and hyaluronidase-fihj) for treating high-risk smoldering multiple myeloma (HR-SMM), a precursor to active multiple myeloma. This marks the first and only approved therapy for early intervention before the disease progresses.
About Smoldering Multiple Myeloma
Smoldering multiple myeloma is an asymptomatic stage without visible signs or symptoms, preceding active multiple myeloma.
AQUILA Study Results
The FDA approval is grounded in the Phase 3 AQUILA study, which compared Darzalex Faspro to active monitoring ("Watch and Wait") in patients with HR-SMM. The study showed:
- A significant improvement in progression-free survival (PFS) as the primary endpoint.
- Darzalex Faspro reduced the risk of disease progression to active myeloma or death by 51% compared to active monitoring.
- At a median follow-up of 65.2 months, 63.1% of patients on Darzalex Faspro remained free from progression to active myeloma at five years, versus 40.7% in the active monitoring group.
"Darzalex Faspro is the first and only approved treatment for high-risk smoldering multiple myeloma, enabling earlier intervention before the disease progresses to active multiple myeloma."
Additionally, the FDA also approved Caplyta as an add-on therapy for major depressive disorder, expanding treatment options in that area.
Summary
Darzalex Faspro offers a breakthrough for patients with high-risk smoldering multiple myeloma by significantly delaying progression to active disease, based on robust clinical evidence from the AQUILA trial.
Would you like me to include a section explaining Caplyta's new approval as well?