FDA committee votes in favor of Darzalex Faspro for HR-SMM
Oncologic drugs advisory panel backs risk-benefit profile in 6-2 vote
A U.S. Food and Drug Administration (FDA) committee has voted in favor of Darzalex Faspro (daratumumab and hyaluronidase-fihj) to treat high-risk smoldering multiple myeloma (HR-SMM).
The FDA’s Oncologic Drugs Advisory Committee voted 6 to 2 in favor of the benefit-risk profile of Darzalex Faspro in HR-SMM, which refers to early signs of inactive myeloma that is not yet causing any overt symptoms but where there is a high likelihood of progression to active disease. There are no approved treatments for HR-SMM, and typically the disorder is managed with a watch-and-wait approach, in which patients are monitored but don’t receive any treatment until they start to experience active disease that causes overt symptoms.
The FDA is not obligated to follow the recommendations of its advisory committees, but it usually does. The agency is expected to make a final decision on Darzalex Faspro for HR-SMM later this year. The therapy’s developer, Johnson & Johnson, in late 2024 submitted an application seeking the treatment’s approval based on clinical trial data indicating early intervention with Darzalex Faspro leads to better outcomes than the watch-and-wait approach.
“High-risk smoldering multiple myeloma remains a challenging clinical conundrum with no approved therapies, and earlier intervention may delay or even prevent progression to active multiple myeloma,” Peter Voorhees, MD, a researcher at the Atrium Health Levine Cancer Institute who has served as a consultant to Johnson & Johnson, said in a company press release. “We appreciate the balance the committee provided when assessing the risks and benefits of finite treatment at this stage and its recognition of the promise of Darzalex Faspro.”
Disease progression risk lower with Darzalex Faspro
Johnson & Johnson applied for approval of Darzalex Faspro in HR-SMM based on data from a Phase 3 clinical trial called AQUILA (NCT03301220). The study enrolled nearly 400 people with HR-SMM, who were randomly assigned to treatment with Darzalex Faspro or standard, watch-and-wait care.
Results published last year showed that the risk of disease progression or death was 51% lower in patients given Darzalex Faspro. After five years of follow-up, 63.1% of patients given the treatment were still alive without disease progression, compared with 40.8% of those who received watch-and-wait care.
“Early intervention in high-risk smoldering multiple myeloma demonstrated a reduction in the risk of progression or death,” said Sen Zhuang, MD, PhD, vice president of oncology clinical research at Johnson & Johnson Innovative Medicine. “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.”
Darzalex Faspro is an under-the-skin injection formulation of Darzalex (daratumumab), which is approved by the FDA to treat active multiple myeloma in a variety of settings.
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