The FDA has now approved Darzalex Faspro for use in combination with bortezomib, lenalidomide, and dexamethasone (the D-VRd regimen), for adults with newly diagnosed multiple myeloma who are unable to receive a stem cell transplant.
Multiple myeloma is a blood cancer in which abnormal plasma cells (a type of white blood cell found in the bone marrow) multiply and crowd out healthy blood-forming cells.
It is the second most common blood cancer worldwide and has no cure. In 2026, it is expected that about 36,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people will die due to this disease. While some patients don’t show any symptoms initially, most are diagnosed after developing problems such as bone pain or fractures, anemia, fatigue, high calcium levels, kidney issues, or frequent infections. The five-year survival rate is about 60%.
Why Was It Approved?
The FDA’s approval of Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (VRd) was based on a clinical study that showed that this combination therapy was safe and effective and produced stronger and longer-lasting treatment responses, higher rates of no detectable cancer, and a reduced risk for disease progression or death compared with the VRd-only regimen in adults with newly diagnosed multiple myeloma who were either ineligible or did not opt for stem cell transplant. In the phase 3 study, a total of 395 patients were randomly assigned to receive either the D-VRd or standard VRd regimen. The results showed that 52.3% of patients receiving D-VRd vs 34.8% receiving VRd alone achieved minimal residual disease (MRD) negativity (meaning no detectable cancer cells were found using highly sensitive testing) at a median follow-up of 22 months. At a median follow-up of 39 months, D-VRd nearly doubled the rate of sustained MRD negativity lasting at least 12 months compared to that with VRd alone (42.6% vs. 25.3%) and reduced the risk for disease progression or death by 40%.
What Do I Need to Know?
Darzalex Faspro is given as a quick injection under the skin, usually in the abdomen area, by your health care provider. Each dose takes about three to five minutes. In the D‑VRd regimen, treatment for newly diagnosed multiple myeloma starts with a weekly injection of Darzalex Faspro for the first six weeks, followed by an injection once every three weeks until week 24, and then once a month after that. This can continue until your disease progresses or side effects are no longer tolerable.
