Johnson & Johnson's Darzalex injection approved for a four-drug combination therapy in China.

On February 6th, Johnson & Johnson (JNJ.US) announced that its innovative treatment drug Darzalex (daratumumab) subcutaneous injection has officially received approval from the National Medical Products Administration to expand its indications. It can now be used in combination with bortezomib, lenalidomide, and dexamethasone to treat newly diagnosed multiple myeloma in adult patients eligible for autologous stem cell transplantation. This means that patients have the opportunity to receive a four-drug combination regimen based on the subcutaneous injection formulation of daratumumab at the newly diagnosed stage, providing a new treatment option that significantly improves prognosis. This approval was based on the results of the phase III PERSEUS study. This study evaluated two treatment regimens in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation: a four-drug combination regimen based on the subcutaneous injection formulation of daratumumab (DVRd) for induction and consolidation therapy followed by maintenance therapy with daratumumab in combination with lenalidomide; and induction and consolidation therapy with bortezomib, lenalidomide, and dexamethasone (VRd) followed by maintenance therapy with lenalidomide. The overall safety profile of the DVRd regimen was consistent with the known safety profiles of daratumumab subcutaneous injection and the VRd regimen. The most common hematologic adverse reactions (20% incidence) included neutropenia, thrombocytopenia, and anemia. The most common non-hematologic adverse reactions included peripheral neuropathy, fatigue, peripheral edema, fever, upper respiratory tract infection, COVID-19 infection, constipation, diarrhea, back pain, insomnia, asthenia, and rash.