Isatuximab Approved for Sale in China as a Treatment for Multiple Myeloma

Sanofi announced on January 9 that its CD38 monoclonal antibody isatuximab injection has been approved for sale in China. This medication will be used in combination with pomalidomide and dexamethasone to treat adult patients with multiple myeloma (MM) who have received at least one line of therapy (including lenalidomide and a proteasome inhibitor). Isatuximab thus becomes the first hematologic oncology treatment drug approved based on real-world research data from the "Lecang" study as key evidence.

Isatuximab works by targeting specific epitopes on the CD38 receptors on multiple myeloma cells, triggering various mechanisms of action, including programmed tumor cell death (apoptosis) and modulation of the body's immune response. CD38 is highly expressed on multiple myeloma cells and is an important cell surface receptor target for antibody therapies in this disease and other malignancies.

Isatuximab was approved by the FDA in March 2020 for use in combination with pomalidomide and dexamethasone in adult patients with relapsed refractory multiple myeloma who have received at least two prior therapies (including lenalidomide and a proteasome inhibitor). Subsequently, in March 2021, the drug's indications were further expanded, receiving FDA approval for use in combination with carfilzomib and dexamethasone in adult patients with relapsed or refractory multiple myeloma who had previously received 1-3 lines of therapy.

In February 2023, thanks to the "Hong Kong-Macao Drug and Medical Device Connection" policy, isatuximab successfully launched in China's Guangdong-Hong Kong-Macao Greater Bay Area. Multiple myeloma is the second most common malignant tumor in the hematologic system, primarily affecting the elderly population over 60 years old. In China, the overall incidence of this disease is 1.6 per 100,000. Compared to Western countries, Chinese patients are often diagnosed at an advanced stage, with a higher number of high-risk patients, and late relapsed patients frequently face the dilemma of "post-line drug shortages."