Isatuximab Approved in China for Multiple Myeloma Treatment

Sanofi recently announced that isatuximab, a CD38 monoclonal antibody, has received approval for market release in China. This drug, administered alongside pomalidomide and dexamethasone, is specifically designed to treat adult patients suffering from multiple myeloma (MM) who have undergone at least one previous therapy, including lenalidomide and a proteasome inhibitor. This approval marks a significant milestone as isatuximab is now the first hematologic oncology medication sanctioned in China based on real-world data derived from the "Lecang" study.

Isatuximab functions by targeting specific sites on the CD38 receptors of multiple myeloma cells, activating several mechanisms such as programmed cell death (apoptosis) and enhancing the body's immune response. CD38 is prominently expressed in multiple myeloma cells, making it a crucial target for antibody treatments in tackling this disease and other cancers.

In the United States, isatuximab was initially approved by the FDA in March 2020. It was authorized for use with pomalidomide and dexamethasone in adult patients with relapsed or refractory multiple myeloma who had already received two or more treatments, including lenalidomide and a proteasome inhibitor. A year later, in March 2021, further expansion of its indications was approved by the FDA. It was then permitted for use in conjunction with carfilzomib and dexamethasone for adult patients who had experienced relapse or refractory multiple myeloma after undergoing 1-3 lines of therapy.

The availability of isatuximab in China was further facilitated by the "Hong Kong-Macao Drug and Medical Device Connection" policy in February 2023. This policy enabled the drug's launch in the Guangdong-Hong Kong-Macao Greater Bay Area, broadening its accessibility for patients in this region.

Multiple myeloma is recognized as the second most prevalent form of malignant tumor affecting the hematologic system, predominantly impacting individuals over the age of 60. In China, this disease has an incidence rate of 1.6 per 100,000 people. Chinese patients often face unique challenges compared to their Western counterparts, as they are frequently diagnosed at more advanced stages and are more likely to be high-risk cases. Additionally, patients who experience late relapses often encounter difficulties due to a shortage of effective treatments available after initial therapies.

This approval and the introduction of isatuximab in China signal a hopeful advancement for patients battling multiple myeloma, offering a new line of defense in the management of this challenging condition. The drug's ability to target CD38 receptors and its real-world evidence base present promising opportunities for improving outcomes in affected patients. As healthcare professionals in China incorporate isatuximab into treatment regimens, it is anticipated that this will lead to enhanced therapeutic strategies, providing patients with more effective options tailored to their specific needs in combating multiple myeloma.