On September 20, Sanofi announced its CD38 monoclonal antibody Sarclisa (isatuximab)The supplemental Biologics License Application (sBLA) was approved by the FDA for use inCombination of bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of newly diagnosed multiple myeloma patients (NDMM) who are not eligible for transplantation.Sarclisa in the United StatesThe third approved indication. Previously,CDE also accepted the sBLA in May this year.。The FDA's approval this time is mainly based on the positive results of the Phase III IMROZ study. The study enrolled 446 patients.The primary endpoint assessed for adult patients with NDMM who are ineligible for transplantation is progression-free survival (PFS).The results showed that, at a median follow-up of 59.7 months，PFS was significantly prolonged in the Sarclisa group (not reached vs. 54.3 months);Sarclisa GroupThe proportion of patients with PFS reaching 60 months was significantly higher.VRd Group(63.2% vs. 45.2%), the risk of disease progression or death was reduced by 40% (HR=0.60,P<0.001）。
Sarclisa is from SanofiA CD38 monoclonal antibody obtained from ImmunoGen (which has been acquired by AbbVie) canTargeting 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 cellsPlain expression, is the cell surface receptor target for antibody therapy in multiple myeloma and other malignancies.In March 2020, Sarclisa was first approved by the FDA for marketing in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.March 2021,SarclisaApproved by FDA for expanded new indications, for use in combinationSanofiZomibUsed in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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