FDA Approves Sanofi’s CD38 Antibody Sarclisa, Reducing Disease Progression Risk by 40% in Relapsed/Refractory Multiple Myeloma

On the 3rd, the U.S. FDA announced the approval of Sarclisa (isatuximab-irfc), a CD38 antibody developed by Sanofi, for marketing. It is indicated for use in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Multiple myeloma (MM) is a hematologic malignancy caused by the malignant transformation of plasma cells in the bone marrow. Abnormal plasma cells accumulate in the bone marrow, forming tumors in multiple bones throughout the body. These cells not only fail to perform their normal functions but also impair the bone marrow’s ability to produce healthy blood cells. Malignant plasma cells disrupt normal hematopoiesis, leading to decreased blood cell counts, bone damage, and renal impairment. Despite significant advances in the treatment of MM in recent years, most patients still face the challenges of relapse or drug resistance, which pose life-threatening risks.

Isatuximab is a monoclonal antibody targeting the CD38 receptor on the surface of plasma cells, which can trigger multiple distinct mechanisms of action to promote apoptosis and modulate immune responses.

Image source: Sanofi official website

This approval is based on the results of a clinical trial involving 307 patients with relapsed/refractory multiple myeloma who had received at least two prior lines of therapy, including lenalidomide and a proteasome inhibitor. The trial demonstrated that isatuximab in combination with pomalidomide and low-dose dexamethasone reduced the risk of disease progression or death by 40% compared to the active control group receiving pomalidomide and low-dose dexamethasone alone. The median progression-free survival (PFS) in the isatuximab combination group was nearly double that of the active control group (11.53 months vs. 6.47 months). The overall response rate (ORR) was 60.4% in the isatuximab group, compared to 35.3% in the active control group.

“Although there is currently no cure for multiple myeloma, the approval of Sarclisa adds another CD38-targeted treatment option for patients with relapsed disease,” said Richard Pazdur, M.D., Director of the FDA’s Oncology Center of Excellence.

▲Multiple clinical research programs for Isatuximab (Image source: Sanofi official website)

Sanofi has also initiated multiple clinical trials to evaluate the efficacy of isatuximab in combination with different types of standard therapies for treating patients with multiple myeloma (MM) at various disease stages. We look forward to this innovative therapy benefiting more MM patients.

References:

[1] FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma. Retrieved March 2, 2020, from https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-patients-previously-treated-multiple-myeloma

Original Title: FDA Approves Sanofi’s CD38 Antibody for Market Launch, Reducing Risk of Disease Progression by 40%

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