By Fineline Cube Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) combined with bortezomib, lenalidomide, and dexamethasone (D-VRd regimen) for adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). The regimen is the only anti-CD38 monoclonal antibody (mAb)-based therapy approved for NDMM patients, regardless of transplant eligibility.
Regulatory Milestone & Clinical Data
| Item | Detail |
|---|---|
| Company | Johnson & Johnson (NYSE: JNJ) |
| Regimen | Darzalex Faspro + bortezomib, lenalidomide, dexamethasone (D-VRd) |
| Indication | Newly diagnosed multiple myeloma (NDMM) – ASCT-ineligible |
| Approval Basis | Phase III CEPHEUS study |
| Key Efficacy vs. VRd | • Increased depth and duration of response • Significantly reduced risk of disease progression or death • Nearly doubled rate of sustained MRD negativity |
| Strategic Significance | Only anti-CD38 mAb-based therapy approved for NDMM regardless of transplant eligibility |
| Darzalex Faspro Portfolio | 11 MM indications approved in US since May 2020; 5 for first-line NDMM treatment |
Market Impact & Commercial Outlook
- Multiple Myeloma Market: Global NDMM market valued at $12 billion : in 2025, growing at 6% CAGR driven by aging population and earlier diagnosis
- Competitive Landscape: D-VRd positions J&J against standard VRd and emerging quadruplet regimens; anti-CD38 backbone offers differentiation in ASCT-ineligible segment
- Revenue Potential: Analysts project $2–3 billion peak annual sales for D-VRd in NDMM, complementing Darzalex’s existing $8 billion-plus global franchise
- Strategic Value: Expands Darzalex Faspro’s first-line dominance in transplant-ineligible patients, a 40% subset of NDMM population
- Next Steps: Launch activities begin Q2 2026; physician education on MRD negativity benefit targeted at community oncology centers
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial expectations, market penetration, and revenue projections for Darzalex Faspro D-VRd regimen. Actual results may differ due to competitive dynamics, physician adoption rates, and reimbursement negotiations.-Fineline Info & Tech