Shots:
- The EC has approved Darzalex SC (daratumumab) for the treatment of adults with high‑risk smouldering multiple myeloma (SMM)
- Approval was based on the P-III (AQUILA) study data assessing Darzalex SC monotx. vs active monitoring in high-risk SMM pts (n=390)
- At a mFU of 65.2mos., trial showed improved PFS, with 63.1% vs 40.8% pts alive & progression-free at 60mos. (mPFS: unreached vs 22.1mos.). Trial also depicted improved OS (93% vs 86.9% at 5yrs.), & ORR (63.4% vs 2%), with median time to 1L MM treatment unreached vs 50.2mos.
Ref: GlobeNewsWire| Image: Johnson & Johnson | Press Release
Related News:- Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)
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