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.

A closeup of pills in a pharmacy, representing the high quality medications of the company.

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.