Johnson & Johnson files for FDA approval of Darzalex Faspro-based regimen

Johnson & Johnson announced the submission of a supplemental Biologics License Application, or sBLA, to the FDA for approval of a new indication for Darzalex Faspro in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma 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% of patients achieved minimal residual disease-negativity with D-VRd and the risk of progression or death was reduced by 43%. The CEPHEUS study evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone for NDMM patients for whom ASCT was not planned as initial therapy. “Darzalex Faspro-based therapies continue to be at the forefront of multiple myeloma research. We’re encouraged that the FDA Oncologic Drugs Advisory Committee recently voted in favor of MRD-negativity as an acceptable endpoint in multiple myeloma trials. CEPHEUS is the first registrational study with a primary endpoint of MRD-negativity filed by Johnson & Johnson in multiple myeloma,” said Craig Tendler, M.D., Vice President, Late Clinical Development and Global Medical Affairs, Innovative Medicine, Johnson & Johnson. “The data from CEPHEUS add to the body of evidence for Darzalex Faspro in newly diagnosed multiple myeloma and, together with the results of the PERSEUS study, demonstrate the potential benefit of this quadruplet regimen for newly diagnosed patients, regardless of transplant eligibility.”