WASHINGTON, Feb. 2, 2026 – The U.S. Food and Drug Administration (FDA) recently approved daratumumab and hyaluronidase‑fihj (Darzalex Faspro™) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are not eligible for stem cell transplant.
“This approval represents an important step forward for people who are newly diagnosed with this disease,” said Lore Gruenbaum, Ph.D., Chief Scientific Officer of Blood Cancer United. “Historically, patients who cannot undergo stem cell transplant have had fewer effective options.”
The FDA’s decision was supported by data from the CEPHEUS trial, which evaluated the safety and effectiveness of the four‑drug combination in 197 newly diagnosed patients compared with VRd alone in 198 patients.
Patients who received the daratumumab-containing combination had a higher rate of undetectable minimal (or measurable) residual disease (MRD) (52% vs. 35%). Adding daratumumab and hyaluronidase to the VRd combination reduced the risk of disease progression or death by 40%.
“We’ve made tremendous progress in multiple myeloma in recent years, but we still need frontline therapies that can deliver deeper, longer‑lasting responses and combination therapies are a promising way to get there,” said Dr. Gruenbaum.
Blood Cancer United supports the science that makes drug approvals possible
The CEPHEUS trial was led by Saad Usmani, M.D., an internationally recognized myeloma expert at Memorial Sloan Kettering Cancer Center in New York whose work has helped shape how the disease is treated today.
Blood Cancer United has provided financial support for Dr. Usmani’s work and the work of countless other talented physicians and scientists advancing care for multiple myeloma.
We currently have active funding commitments of over $33 million in 34 multi-year myeloma research grants. Our funding helped support the foundational work on the CD38 protein that paved the way for the development of daratumumab and other CD38-directed treatments that are standard of care today.
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