Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

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• FDA has approved Darzalex Faspro (daratumumab & hyaluronidase-fihj) for high‑risk SMM based on the P-III (AQUILA) study assessing Darzalex Faspro alone vs active monitoring in adults, which met its 1EP of improved PFS by 51%, with 63.1% vs 40.7% pts progression-free at a mFU of 65.2mos.
• Trial also showed an improved ORR (63.4% vs 2%) & longer time to 1L MM treatment (unreached vs 50.2mos.); in post hoc analysis, 41% pts met the Mayo 2018 HR-SMM classification & had unreached mPFS vs 22.1mos.; data published in The NEJM
• Also, AQUILA subgroup analysis on Darzalex Faspro monotx. in high-risk SMM pts using IMWG 2020 ± cytogenetic risk will be presented at ASH’25

Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release

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