The US FDA issued a new approval to Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj), allowing use in combination with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone (VRd) as a frontline regimen for adults with newly diagnosed multiple myeloma (MM). The news reinforces quadruplet regimens as the frontline backbone for MM, and marks Darzalex Faspro’s 11th indication for the disease.
As per the FDA’s notice, the approval was based on data from the Phase III CEPHEUS trial in which the Darzalex Faspro-based quadruplet regimen led to higher minimal residual disease (MRD) negativity rates and improved progression-free survival (PFS) compared with VRd alone in patients unable to undergo stem cell transplant.
The MRD negativity rate was 52.3% in the Darzalex Faspro-VRd arm and 34.8% in the VRd alone cohort, with a PFS hazard ratio was 0.60. Darzalex Faspro is the subcutaneous version of intravenous drug Darzalex, combining an anti-CD38 monoclonal antibody with hyaluronidase to facilitate the easier administration path. The drug was first approved in 2020, with the 11 MM indications including frontline use in transplant-eligible and transplant-ineligible patients and for high-risk smoldering MM. It remains the only subcutaneous CD38-directed antibody therapy approved for the disease in the US.