Sanofi's CD38 antibody combination therapy receives FDA approval to reduce the risk of disease progression by 45%

MM is the second most common hematological malignancy.

Sarclisa is a monoclonal antibody that specifically binds to the CD38 receptor expressed on MM cells.

The FDA approval is based on the results of the randomized, double-blind, open-label phase 3 clinical trial IKEMA.

In China, isatuximab was approved for clinical use in July last year for the treatment of high-risk smoking multiple myeloma.

One is a randomized, open, international multi-center phase 3 clinical trial, which aims to compare isatuximab combined with bortezomib, lenalidomide and dexamethasone, compared with bortezomib, lenalidomide and dexamethasone, in Benefits in extending the progression-free survival of patients newly diagnosed with multiple myeloma who are not suitable for transplantation;

The other is a phase 1 clinical study to evaluate the pharmacokinetics, safety and preliminary efficacy of isatuximab in Chinese patients with relapsed and/or refractory multiple myeloma.