Johnson & Johnson's (JNJ.US) cancer combination therapy is anticipated to receive EU approval for the treatment of multiple myeloma.

Johnson & Johnson (JNJ.US) recently announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the extension of the indication for Darzalex (daratumumab) subcutaneous (SC) formulation, used in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd), for the first-line treatment of newly diagnosed multiple myeloma in adult patients. The CHMP's recommendation was based on data from the phase 3 clinical trial CEPHEUS, which evaluated the efficacy and safety of D-VRd versus VRd in patients who are ineligible for transplant or who do not plan to have an autologous stem cell transplant (ASCT) as initial therapy. The study data were previously presented at the 2024 International Myeloma Society (IMS) and 2024 American Society of Hematology (ASH) annual meetings. Darzalex SC is the first anti-CD38 antibody that can be administered subcutaneously, reducing the time patients spend receiving treatment from hours to minutes. It has already been approved for eight indications for multiple myeloma, including four for first-line treatment.