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US FDA Votes in Favour of Darzalex Faspro® Benefit-Risk Profile

May 20, 2025

On 20 May 2025, Johnson & Johnson (J&J) announced that the US FDA has voted (6-2) in favour of the benefit-risk profile of single-agent Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).  J&J submitted its application to the US FDA for approval of this indication in November 2024.