The U.S. Food and Drug Administration (FDA) advisory committee voted in support of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in treating adults with high-risk smoldering multiple myeloma (HR-SMM). The Oncologic Drugs Advisory Committee (ODAC) voted 6-2, indicating a potentially landmark treatment in the control of this precursor disease to multiple myeloma.
If ultimately approved by the FDA, DARZALEX FASPRO® will be the first-ever therapy to be specifically indicated for delaying or preventing the disease progression from HR-SMM to active multiple myeloma, a serious and incurable type of blood cancer.
Early intervention in high-risk smoldering multiple myeloma demonstrated a reduction in the risk of progression or death,
The proactive approach demonstrated in the AQUILA study is an example of Johnson & Johnson’s aspiration to get in front of cancer by providing a platform to treat disease before progression to active disease.
Sen Zhuang
Smoldering multiple myeloma (SMM) is an asymptomatic precursor phase of multiple myeloma. HR-SMM patients are at high risk of developing active disease, which can lead to important complications like bone damage, renal failure, and anemia. Observation is the current standard strategy for HR-SMM, and treatment is initiated only after the disease progresses and symptoms appear.
The favorable ODAC recommendation is a critical milestone for Johnson & Johnson, the developer of DARZALEX FASPRO®. The company stated that this news supports their vision for the future of oncology, with early diagnosis and early treatment becoming the new norm, with the hope of getting closer to a cancer-free world. The committee’s action highlights a turning point in the potential to change the course of the disease and treatment pattern for patients who are at the most significant risk of developing active multiple myeloma.
Although the FDA is not obligated to follow the committee’s recommendation, it generally considers its views when deciding on final approval. The approval of DARZALEX FASPRO® for this condition could provide a new aggressive treatment option for individuals living with uncertainty about HR-SMM.
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