Sanofi CD38 Antibodies EU Approved for Listing
Last Update: 2020-06-17
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Recently, the European Commission (EC) announced the approval of Sanofi's CD38-targeted antibody drug Sarclisa (isatuximab), in conjunction with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with recurrent and refractive multiple myeloma (MM)These patients have previously received at least two treatments, including lenalidomide and protease inhibitors, and the disease is not controlled during the last treatment and shows progressionapproval is based on data from the critical 3-phase ICARIA-MM studyThe study was the first phase 3 study to assess the positive results of the Sarclisa Joint Standard Care (pom-dex) programmeThe results showed that Sarclisa's joint pom-dex showed a statistically significant increase in disease-free survival (PFS) compared to standard care (median PFS: 11.53 months vs 6.47 months), with a significant increase in total mitigation rate (60.4) % vs 35.3%, p 0.0001), a 40% significant lying risk of disease progression or death (HR s 0.596; 95% CI: 0.44-0.81; p-0.0010)In each subgroup, Sarclisa combination therapy showed therapeutic benefits, including patients with high risk cytogenetics, patients 75 years and older, patients with renal insufficiency, and patients with lenalidomide who were incurablethe most common adverse reactions toSarclisa (in 20% or more patients) were neutrophila (46.7%), infusion reaction (38.2%), pneumonia (30.9%), upper respiratory tract infection (28.3%), diarrhea (25.7%) and bronchitis (23.7%)The most common serious adverse reactions were pneumonia (9.9%) and a decrease in febrile neutrophils (6.6%)Sarclisa's active drug ingredient is an IgG1 interclining monoclonal antibody that targets specific epitopes of pulp cell CD38 receptors, triggering a variety of unique mechanisms of action, including promoting immunomodulation activity and programmed tumor cell death (apoptosis)CD38 shows a high level of expression on MM cells and is an important target for cell surface receptors treated with antibodies in MM and other malignant tumorsin the United States, Sarclisa was approved in early MarchSarcisa will be the first direct competitor to Darzalex, the Johnson and Johnson CD38 target drug, which went public in 2015 with global sales of $2.998 billion in 2019Analysts at Jefferies, a Wall Street investment bank, expect Sarcisa's annual sales peak to exceed $1bnSanofi is also evaluating Sarclisa's potential for other hematologic malignancies and solid tumorsSource: Sanofi European Commission approves Sarcisa ® (isatuximab) for adults with relapsed and rye refract multiple myeloma
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