The FDA has approved Darzalex Faspro (daratumumab with hyaluronidase) combined with bortezomib, lenalidomide, and dexamethasone (VRd) for adults newly diagnosed with multiple myeloma who cannot have a stem cell transplant.
The approval is based on a study of 395 patients showing that adding Darzalex Faspro to VRd improved outcomes: 52.3% of patients achieved MRD negativity versus 34.8% with VRd alone, and the risk of disease progression or death was reduced by 40%.
The recommended dose is 1,800 mg daratumumab with 30,000 units hyaluronidase. Side effects include allergic reactions, infections, low blood counts, and risks to a fetus. It may also affect blood cross-matching. This treatment is specifically for patients medically ineligible for transplants.