Janssen's Daratumumab Gains New Indication in China for Multiple Myeloma Treatment

By Medicine View

China’s National Medical Products Administration (NMPA) recently announced that Janssen, a subsidiary of Johnson & Johnson, has received approval in China for a new indication of its CD38 monoclonal antibody daratumumab injection (daratumumab, trade name: DARZALEX). Notably, in October this year, the subcutaneous injection form of daratumumab was just approved in China for the treatment of patients with primary light chain amyloidosis.

Image Source: NMPA Official Website

Public data shows that daratumumab is the world's and China's first approved fully human monoclonal antibody targeting CD38. It can specifically recognize CD38, which is highly expressed on malignant plasma cells in multiple myeloma (MM), with high affinity, thereby inducing tumor cell death through various immune-mediated mechanisms. Since its introduction in 2015, daratumumab has been approved for marketing in many countries worldwide, benefiting a wide range of patients. According to Johnson & Johnson’s 2020 financial report, daratumumab achieved sales of $4.19 billion for the whole of last year, indicating the significant clinical demand for this drug.

In China, daratumumab was conditionally approved by the NMPA for the first time in July 2019 for monotherapy to treat adult patients with relapsed and refractory multiple myeloma who had previously received treatments including proteasome inhibitors (PI) and immunomodulatory agents and showed disease progression at the time of their last treatment. In April 2021, the product was further approved by the NMPA for use in combination with lenalidomide and dexamethasone or with bortezomib and dexamethasone to treat adult patients with multiple myeloma who had received at least one prior line of therapy. Additionally, Janssen Pharmaceuticals submitted a new indication application for daratumumab in China in February 2021, which has now been approved by the NMPA.

In addition to the above-mentioned indications already approved in China, daratumumab has also been approved in the United States for various indications of multiple myeloma, including: 1) in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who are refractory to lenalidomide and proteasome inhibitors; 2) in combination with bortezomib, melphalan, and prednisone for the treatment of newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplantation (ASCT); 3) in combination with lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma patients who are not eligible for ASCT; 4) in combination with bortezomib, thalidomide, and dexamethasone (also known as the Darzalex-VTd regimen) for the first-line treatment of newly diagnosed multiple myeloma patients who are eligible for ASCT; 5) in combination with carfilzomib and dexamethasone (DKd regimen) for the treatment of patients with relapsed/refractory multiple myeloma who have received 1-3 prior lines of therapy, etc.

Multiple Myeloma (MM) is a malignant hematologic cancer caused by the abnormal proliferation of plasma cells in the bone marrow. The cancerous plasma cells disrupt the production of normal blood cells, leading to decreased blood cell counts, bone destruction, and kidney damage. While the emergence of innovative therapies over the past decade has significantly transformed the treatment landscape for MM, many patients still experience disease relapse and develop resistance to existing treatments. Therefore, these patients with relapsed/refractory multiple myeloma continue to require new therapeutic options.

Congratulations to Johnson & Johnson's Daratumumab for gaining another new indication approval in China. It is hoped that this product will benefit more patients with multiple myeloma.

References:

[1] Information on Pending Drug Approval Documents Released on November 12, 2021. Retrieved Nov 12, 2021, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20211112084913129.html

[2]DARZALEX® (Daratumumab) Shows Overall Survival Benefit and Continued Improvement in Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplant. Retrieved Dec 9, 2019, from https://www.jnj.com/darzalex-daratumumab-shows-overall-survival-benefit-and-continued-improvement-in-progression-free-survival-in-patients-with-newly-diagnosed-multiple-myeloma-who-are-ineligible-for-transplant

▽Follow 【WuXi AppTecGermany】WeChat Official Account