Sanofi's CD38 Monoclonal Antibody Sarclisa Receives FDA Priority Review for New Indication in Newly Diagnosed Multiple Myeloma

May 27,SanofiAnnounced that the FDA has accepted its CD38 monoclonal antibodySarclisa（Isatuximab) UnitedBortezomib、LenalidomideAndDexamethasone(VRd) treatment for newly diagnosed multiple myeloma patients (NDMM) who are not eligible for transplant, submitted a supplemental application for a new indication (sBLA) and has been granted priority review. If approved, Sarclisa will become the firstCombined Standard TherapyVRd TherapyThis class of patients' CD38 drugs will also become the third indication for Sarclisa in treating multiple myeloma.Last week, the CDE also accepted Sarclisa's marketing application for this indication.

SarclisaTargeting the specific epitope of the CD38 receptor on multiple myeloma cells can trigger multiple different 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.Plain expression, is the cell surface receptor target for antibody therapy in multiple myeloma and other malignancies.

In December last year, Sanofi announced that the IMROZ trial had met its primary endpoint, showing that in newly diagnosed MM patients ineligible for transplant, Sarclisa combined with VRd significantly reduced the risk of disease progression or death compared to VRd alone.

March 2020,SarclisaFirst FDA Approval for Market Launch, in CombinationPomalidomideAnd dexamethasone for the treatment of relapsed patients who have previously received at least two prior therapies (including lenalidomide and a proteasome inhibitor)Sex orAdult patients with refractory multiple myeloma.

March 2021,SarclisaApproved by the FDA to expand new indications, in combinationCarfilzomibIn combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

"Sarclisa represents a potential best-in-class (BIC) treatment option, and the acceptance of this sBLA, along with the FDA's Priority Review designation, reinforces our confidence in its role," said Dietmar Berger, MD, Chief Medical Officer and Global Head of Development at Sanofi. "Despite recent advances in multiple myeloma treatment, there remains an unmet clinical need for first-line therapies, especially for patients who are not eligible for transplant and may face poor prognosis. This marks a crucial step forward in advancing this combination for a difficult-to-treat cancer."

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