Johnson & Johnson (JNJ.US) Daratumumab Injection Combination Regimen Approved in China

On February 6th, Johnson & Johnson (JNJ.US) announced that its innovative therapeutic drug, Darzalex (subcutaneous injection of daratumumab), has officially received approval from the National Medical Products Administration to expand its indications. It will now be used in combination with bortezomib, lenalidomide, and dexamethasone to treat newly diagnosed multiple myeloma adult patients eligible for autologous stem cell transplantation. This means patients at the newly diagnosed stage will have the opportunity to receive a four-drug combination regimen based on daratumumab subcutaneous injection, offering a new treatment option that significantly improves prognosis.

This approval is based on the results of the Phase III PERSEUS study. The study compared two treatment regimens in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation: a four-drug combination regimen based on daratumumab subcutaneous injection (DVRd) for induction and consolidation, followed by daratumumab subcutaneous injection combined with lenalidomide for maintenance; and a regimen of bortezomib, lenalidomide, and dexamethasone (VRd) for induction and consolidation, followed by lenalidomide for maintenance.

The overall safety profile of the DVRd regimen was consistent with the known safety characteristics of daratumumab subcutaneous injection and VRd. The most common hematologic adverse reactions (incidence ≥20%) 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, weakness, and rash.