Janssen's Daratumumab Receives Priority Review Designation in China for Two New Multiple Myeloma Indications

On October 21, the latest public notice on the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration indicated that two marketing applications for daratumumab injection, a CD38 monoclonal antibody developed by Janssen, a subsidiary of Johnson & Johnson, have been included in the list of drugs proposed for priority review. Publicly available information shows that daratumumab is the world’s first approved fully human monoclonal antibody targeting CD38. The drug had previously been approved in China as a monotherapy for adult patients with multiple myeloma. The two submissions this time are marketing applications for new indications of daratumumab in the treatment of multiple myeloma.

Source: CDE Official Website

CD38 antigen was discovered in 1980 and is a type II transmembrane glycoprotein. The ligand for CD38 is CD31, and the interaction between CD38 and its ligand CD31 plays a crucial role in regulating cell migration, receptor-mediated adhesion, and signal transduction. Studies have shown that CD38 is highly expressed in many malignant hematologic cancers, particularly in multiple myeloma, making CD38 a target for the development of therapeutic antibody drugs for multiple myeloma.

Daratumumab is a CD38 monoclonal antibody developed by Janssen. According to an earlier press release issued by Janssen, daratumumab can specifically recognize CD38, which is highly expressed on malignant plasma cells in multiple myeloma, with high affinity, thereby inducing tumor cell death through various immune-mediated mechanisms.

In November 2015, daratumumab received its initial approval from the U.S. FDA for the treatment of patients with multiple myeloma. According to publicly available information, it was the first fully human monoclonal antibody targeting CD38 to be approved and marketed globally. Since its launch in 2015, daratumumab has received multiple FDA approvals expanding its indications for the treatment of patients with multiple myeloma.

In China, daratumumab was first granted conditional approval for marketing in July 2019, indicated as monotherapy for adult patients with relapsed and refractory multiple myeloma, including those who had previously received at least one proteasome inhibitor and one immunomodulatory agent and demonstrated disease progression during or after their last treatment. Notably, public information indicates that this is also the first CD38 monoclonal antibody approved for marketing in China.

In July 2020, Johnson & Johnson submitted two new marketing applications for daratumumab injection in China. According to the CDE website, the indications for which daratumumab is applying for market approval are—used in combination with lenalidomide and dexamethasone or with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy.

Multiple myeloma is the second most common hematologic malignancy, with over 130,000 newly diagnosed cases globally each year. Despite available treatments, multiple myeloma remains an incurable malignancy, and most patients experience relapse after treatment or during remission. The advent of CD38 monoclonal antibodies has provided new options for patients with multiple myeloma, particularly those with relapsed and refractory disease.

References:

[1] Center for Drug Evaluation (CDE), National Medical Products Administration of China. Retrieved Oct 21, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=21#

[2] Johnson & Johnson Official Website and Public Information

Source: Pharmaceutical Horizon

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