强生(JNJ.US)达雷妥尤单抗注射液四药联合方案在华获批

Core Viewpoint - Johnson & Johnson (JNJ.US) announced the approval of its innovative treatment drug Daratumumab injection for expanded indications, providing a new treatment option for adult patients with newly diagnosed multiple myeloma suitable for autologous stem cell transplantation [1] Group 1: Approval and Treatment Options - The drug has been approved by the National Medical Products Administration for use in combination with Bortezomib, Lenalidomide, and Dexamethasone [1] - Patients will have the opportunity to receive a four-drug combination therapy based on Daratumumab injection at the newly diagnosed stage, significantly improving prognosis [1] Group 2: Clinical Study Results - The approval is based on the results of the Phase III PERSEUS study, which compared two treatment regimens for newly diagnosed multiple myeloma patients suitable for autologous stem cell transplantation [1] - The study evaluated a four-drug combination regimen (DVRd) using Daratumumab injection for induction and consolidation therapy, followed by maintenance therapy with Daratumumab and Lenalidomide [1] Group 3: Safety Profile - The overall safety profile of the DVRd regimen is consistent with the known safety characteristics of Daratumumab injection and the VRd regimen [1] - Common hematological adverse reactions (incidence ≥20%) include neutropenia, thrombocytopenia, and anemia, while non-hematological adverse reactions include peripheral neuropathy, fatigue, peripheral edema, fever, upper respiratory infections, COVID-19, constipation, diarrhea, back pain, insomnia, weakness, and rash [1]