FDA Approves New Quadruplet Regimen for Transplant-Ineligible Multiple Myeloma Patients
The U.S. Food and Drug Administration (FDA) has approved a new treatment regimen for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The regimen, known as DVRd, combines DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone. This approval is based on the Phase 3 CEPHEUS study, which demonstrated a significant improvement in minimal residual disease (MRD)-negativity rates compared to the previous standard regimen. The study showed that DVRd achieved a 52.3% MRD-negativity rate at a median follow-up of 22 months, compared to 34.8% with the previous regimen. This marks the third indication for DARZALEX FASPRO® in transplant-ineligible patients, reinforcing its role in the treatment landscape for multiple myeloma. 
