Posted by Michael Wonder on 11 Oct 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab) SC based quadruplet regimen for newly diagnosed multiple myeloma patients
10 October 2024 - Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy.
Janssen-Cilag today announced the submission of a type II variation application to the EMA seeking approval for an indication extension of Darzalex (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma.
