Johnson & Johnson's blockbuster drug daratumumab gains new indications in China

ArticleMedicine Guanlan

The latest announcement by the National Food and Drug Administration (NMPA) of China shows that the CD38 monoclonal antibody daratumumab injection (daratumumab, trade name: Zhaoke) of Xi’an Janssen, a subsidiary of Johnson & Johnson, has new adaptations The disease was approved in China

Image source: NMPA official website

Public information shows that daratumumab is the first fully human monoclonal antibody targeting CD38 approved globally and in China

In China, daratumomab was first approved for marketing by NMPA conditionally in July 2019.

In addition to the above-mentioned indications that have been approved in China, daratumomab has also been approved for multiple myeloma indications in the United States, including: 1) combined with pomalidomide and dexamethasone, Treatment of patients with relapsed multiple myeloma resistant to lenalidomide and proteasome inhibitors; 2) Combined with bortezomib, melphalan and prednisone, the treatment is not suitable for autologous stem cell transplantation (ASCT) Newly diagnosed multiple myeloma patients; 3) combined with lenalidomide and dexamethasone to treat newly diagnosed multiple myeloma patients who are not suitable for ASCT; 4) combined with bortezomib, thalidomide and dexamethasone Combination of dexamethasone (also known as Darzalex-VTd therapy), first-line treatment is suitable for patients with newly treated multiple myeloma using ASCT; 5) combined use with carfilzomib and dexamethasone (DKd regimen) for treatment Patients with relapsed/refractory multiple myeloma who have received 1-3 lines of treatment in the past

Multiple myeloma is a malignant blood cancer caused by abnormal proliferation of plasma cells in the bone marrow

Congratulations to Johnson & Johnson for its approval of another new indication in China, and hope that this product will benefit more patients with multiple myeloma

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[1] On November 12, 2021, the drug approval document pending information is released.