FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma

THURSDAY, Nov. 13, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a single-agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM).Darzalex Faspro is now the first and only approved treatment for HR-SMM.The approval is based on results from the phase 3 AQUILA study, which evaluated the efficacy and safety of Darzalex Faspro compared to active monitoring. Using the International Myeloma Working Group diagnostic criteria, the authors of the AQUILA study observed a significant improvement in the primary end point of progression-free survival with Darzalex Faspro, reducing the risk for disease progression to active multiple myeloma or death by 51 percent. After a median follow-up of 65.2 months, 63.1 percent of patients receiving Darzalex Faspro had not progressed to active myeloma at five years, compared with 40.7 percent in the active monitoring group. Additionally, patients treated with Darzalex Faspro had a higher response rate than those treated with active monitoring (63.4 versus 2.0 percent). The median time for receipt of first-line multiple myeloma treatment was delayed with Darzalex Faspro versus active monitoring (not reached versus 50.2 months)."With today's approval, patients with HR-SMM will now be able to receive this treatment before they progress to active multiple myeloma, giving us the opportunity to shift the treatment paradigm and bring hope to people who are impacted by this disease," Jordan Schecter, M.D., from Johnson & Johnson Innovative Medicine, said in a statement.Approval of Darzalex Faspro was granted to Johnson & Johnson.More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma

Related Stories