US FDA Votes in Favor of Benefit-Risk Profile of Johnson & Johnson's DARZALEX FASPRO

On May 20, Johnson & Johnson (NYSE:JNJ) announced that the FDA Oncologic Drugs Advisory Committee/ODAC voted 6-2 in favor of the benefit-risk profile of single-agent DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for treating adult patients with high-risk smoldering multiple myeloma (HR-SMM).

This recommendation is a step towards potentially making DARZALEX FASPRO the first treatment to delay or prevent the progression of this condition to active multiple myeloma.

An application for this approval was submitted to the FDA in November 2024. Currently, there are no approved treatments specifically for HR-SMM. The ODAC's decision was based on data from the Phase 3 AQUILA study. This was a randomized and open-label trial that evaluated the efficacy and safety of DARZALEX FASPRO versus active monitoring in HR-SMM patients.

Smoldering multiple myeloma is an asymptomatic intermediate stage of multiple myeloma. However, ~50% of patients with HR-SMM are likely to develop active disease within 2 to 3 years. The current standard of care for SMM is active monitoring, which can lead to therapeutic intervention only after the detection of end-organ damage. Multiple myeloma is a blood cancer affecting plasma cells in the bone marrow, and it remains incurable. DARZALEX FASPRO received US FDA approval in May 2020 and is currently approved for 9 indications in multiple myeloma, including 4 for frontline treatment.

Johnson & Johnson (NYSE:JNJ) engages in the R&D, manufacture, and sale of various products in the healthcare field worldwide. In August 2012, Janssen Biotech Inc. (a subsidiary of Johnson & Johnson) and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture, and commercialize daratumumab. This is the active ingredient in DARZALEX FASPRO.

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Disclosure: None. This article is originally published at Insider Monkey.