Type II variation application to the EMA for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients
“Daratumumab SC-based therapies continue to be at the forefront of multiple myeloma research. CEPHEUS is the first registrational study with a primary endpoint of MRD-negativity, supported by key secondary endpoints such as progression-free survival, filed by Johnson & Johnson in multiple myeloma,” said Craig Tendler, M.D., Vice President, Clinical Development, Diagnostics, and Global Medical Affairs, Innovative Medicine, Johnson & Johnson. “The data from CEPHEUS add to the body of evidence for daratumumab SC 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.”
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