Pharmaceutical, biotechnology and medical technologies corporation Johnson & Johnson (NYSE:JNJ) announced on Monday that it has submitted a supplemental Biologics License Application to the US FDA for DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd).

This application seeks approval for treating newly diagnosed multiple myeloma (NDMM) patients ineligible for or deferring autologous stem cell transplant (ASCT).

Data from the Phase 3 CEPHEUS study supports the submission, showing 60.9% of patients achieved minimal residual disease (MRD)-negativity with D-VRd, reducing the risk of progression or death by 43%. D-VRd demonstrated superior response rates and durability compared to the VRd regimen, with a complete response rate of 81.2%. Sustained MRD-negativity also favored D-VRd at 48.7% vs 26.3% for VRd.

The study enrolled 396 patients across 13 countries. Safety profiles for D-VRd were consistent with those of DARZALEX FASPRO and VRd.