U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma

Core Insights - The FDA Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO® for treating high-risk smoldering multiple myeloma (HR-SMM), marking a significant step in the treatment landscape for this condition [1][2][3] Company Insights - Johnson & Johnson aims to transform oncology care by advocating for early intervention in high-risk smoldering multiple myeloma, potentially delaying or preventing progression to active multiple myeloma [4][6] - The company emphasizes its commitment to evolving treatment paradigms for multiple myeloma, aligning with its vision for a future where early diagnosis and treatment are standard [4][5] Industry Insights - Currently, there are no approved treatments specifically for HR-SMM, with an estimated 35,000 new multiple myeloma cases expected in the U.S. in 2024, of which approximately 15% are classified as smoldering [3][7] - The standard of care for smoldering multiple myeloma is active monitoring, which may delay therapeutic intervention until significant disease progression occurs [3][8] - The AQUILA study, a Phase 3 trial, demonstrated that early intervention with DARZALEX FASPRO® could reduce the risk of progression or death in patients with HR-SMM [4][6]