Sanofi CD38 antibody EU approved for listing

Recently, the European Commission (EC) announced the approval of Sanofi's CD38 target antibody drug Sarclisa (isatuximab), in conjunction with pomalidomide and dexamethasone (pom-dex), for the treatment of adult patients with recurrent and refractory multiple myeloma (MM)Such patients had previously received at least two treatments, including lenalidomide and protease inhibitors, and the disease was not controlled during the final treatment to show progressionThis approval is based on data from the critical 3 icARIA-MM studyThe study is the first phase 3 study to assess positive results from the Sarclisa Joint Standard Care (pom-dex) programmeThe results showed a significant increase in the statistical lyse duration of disease (PFS) compared to standard care by Sarclisa combined pom-dex (median PFS: 11.53 months vs 6.47 months) and a significant increase in the overall mitigation rate (60.4 months) % vs 35.3%, p 0.0001), a 40% significant reduction in the risk of disease progression or death (HR: 0.596; 95% CI: 0.44-0.81; p.0010)In each subgroup, Sarclisa combination therapy showed therapeutic benefits, including patients with high-risk cytogenetics, patients 75 years of age and older, patients with renal insufficiency, and patients with incurable lenalidomideThe most common adverse reactions in Sarclisa (in 20% or more patients) were neutroperatic granulocytic reduced (46.7%), infusion reactions (38.2%), pneumonia (30.9%), upper respiratory tract infections (28.3%), diarrhea (25.7%) and bronchitis (23.7%)The most common severe adverse reactions were pneumonia (9.9%) and a reduction in febrile neutrophils (6.6%)Sarclisa's active pharmaceutical ingredient, is an IgG1 chimeric monoclonal antibody that targets specific epitopes of plasma cell CD38 receptors, triggering a variety of unique mechanisms of action, including promoting immunomodulatory activity and procedural tumor cell death (apoptosis)CD38 presents high levels of expression on MM cells and is an important target for cell surface receptors for antibody therapy in MM and other malignant tumorsin the United States, Sarclisa was approved in early MarchSarclisa will be the first direct competitor to Johnson and Johnson CD38 target drug Darzalex, which went on sale in 2015 and has global sales of $2.998 billion in 2019Analysts at Jefferies, a Wall Street investment bank, expect Sarclisa's annual sales to peak at more than $1bnSanofi is also evaluating Sarclisa's potential to treat other blood system malignancies and solid tumors