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.
Johnson & Johnson seeks approval for DARZALEX FASPRO in smoldering multiple myeloma
FDA Panel supports IceCure's ProSense Cryoablation for early-stage breast cancer
Dizal submits NDA to US FDA for sunvozertinib in treating NSCLC with EGFR exon 20 mutations
Naitive Technologies enters strategic agreement with Parvizi Surgical Innovation
Akura Medical's application for trial of Katana Thrombectomy System receives US FDA approval
FDA accepts Ionis Pharmaceuticals' donidalorsen New Drug Application
Kazia Therapeutics secures FDA meeting to explore paxalisib pathways for glioblastoma
Boston Scientific to acquire Cortex Inc in strategic expansion of electrophysiology portfolio
Formosa Pharmaceuticals signs licensing agreement with DÁVI Farmaceutica
Amphix Bio receives USD1m SBIR Phase II grant from National Science Foundation