Daratumumab Subcutaneous Injection Approved in China for Newly Diagnosed Multiple Myeloma in Combination Regimen

Beijing News (Reporter Xiulan Zhang) — On February 6, daratumumab injection (subcutaneous injection) (brand name: XEGLYZE) from Johnson & Johnson received approval from the National Medical Products Administration to expand its indications. It will be used in combination with bortezomib, lenalidomide, and dexamethasone to treat newly diagnosed adult multiple myeloma patients who are eligible for autologous stem cell transplantation.

Public data shows that multiple myeloma has a significant age predisposition, with an average onset age between 65 and 75 years. It is often "underestimated" and "misdiagnosed." Patients may initially present with bone pain or seek medical attention due to abnormal kidney function. The first consultations are often in orthopedics or nephrology departments rather than hematology. The disease also exhibits insidious onset, with early lesions quietly developing within the bone marrow without specific manifestations, making it difficult for routine physical examinations to detect in a timely manner. As a result, many patients are diagnosed at an advanced stage of the disease.

It is precisely because of the wide variation in clinical manifestations among multiple myeloma patients that the first-line treatment becomes a crucial phase for achieving the deepest remission and longer survival. There is an urgent need for innovative therapies that can significantly delay disease progression. Studies have shown that induction and consolidation therapy using subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone, followed by maintenance therapy with subcutaneous daratumumab combined with lenalidomide, reduces the risk of disease progression or death by 58%. This regimen has demonstrated potential to enhance the depth of response and prolong the duration of response in patients eligible for autologous stem cell transplantation.

Proofread by Zhao Lin