NICE Greenlights Darzalex Quadruplet D-VRd After Phase III Shows 60.9% MRD Negativity
JNJ•J&J’s cancer therapy Darzalex has secured NICE final draft guidance recommending its use in a four-drug D-VRd regimen for frontline, transplant-ineligible multiple myeloma patients within the NHS. Phase III CEPHEUS data showed 60.9% minimal residual disease negativity at 58.7-month follow-up versus 39.4% with standard VRd, reversing NICE’s January refusal.
1. NICE Approval Expansion
J&J’s Darzalex quadruplet regimen D-VRd has been recommended in final draft guidance for frontline, stem cell transplant-ineligible multiple myeloma patients within the NHS, overturning a January refusal. The regimen still lacks approval for transplant-eligible patients due to ongoing cost-effectiveness concerns.
2. Phase III CEPHEUS Results
The Phase III CEPHEUS trial met its primary endpoint, with 60.9% of patients on D-VRd achieving minimal residual disease negativity at a median 58.7-month follow-up, compared with 39.4% for the standard VRd regimen. These robust long-term data underpinned NICE’s change of heart.
3. Competitive Landscape and Market Implications
With D-VRd’s recommendation, Darzalex may compete head-to-head with Sanofi’s Sarclisa quadruplet, offering a subcutaneous dosing advantage. The expanded UK indication is poised to accelerate Darzalex uptake and bolster J&J’s oncology revenues in Europe.
