Europe - JnJ submits extension application for Darzalex SC in MM

JnJ has announced the submission to the EMA of an indication extension application for Darzalex (daratumumab) subcutaneous (SC) formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM).

This submission was based on data from the Phase 3 CEPHEUS study, 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.

Reference link: JnJ press release