Results from CEPHEUS study highlight DARZALEX FASPRO® quadruplet regimen as a potential standard of care in newly diagnosed patients regardless of transplant eligibility
New indication would be the first FDA-approved treatment regimen for newly diagnosed multiple myeloma based on a study with MRD-negativity as the primary endpoint.
Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) for whom autologous stem cell transplant (ASCT) is deferred or who are ineligible for ASCT.
This submission is supported by data from the Phase 3 CEPHEUS study (NCT03652064), which showed 60.9 percent of patients achieved minimal residual disease (MRD)-negativity with D-VRd and the risk of progression or death was reduced by 43 percent. The CEPHEUS study evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone (VRd) for NDMM patients for whom ASCT was not planned as initial therapy (transplant ineligible or deferred).
