The US Food and Drug Administration has granted approval for daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) to be used in combination with bortezomib, lenalidomide, and dexamethasone (VRd).
This regulatory decision was based on data from the phase 3 CEPHEUS trial, which included 395 patients who were either ineligible for or refused a transplant as their initial therapy.
Results from the study showed that the Darzalex Faspro-VRd regimen significantly outperformed the standard VRd arm. The minimal residual disease (MRD) negativity rate reached 52.3% in the Darzalex Faspro-VRd group compared with 34.8% in the VRd group, according to the FDA. Beyond the improved response rates, the combination also showed a progression-free survival hazard ratio of 0.60.
The combination therapy is now an available option for adults with newly diagnosed multiple myeloma who cannot undergo autologous stem cell transplant or refuse it as initial therapy.
DARZALEX FASPRO® is approved by the FDA as a single-agent therapy for adults with high-risk smoldering multiple myeloma
