New drug for multiple myeloma! Sanofi CD38 antibody Sarclisa approved by the European Union, sword refers to Johnson and Johnson's annual sale of $3 billion heavy drug Darzalex

04 June 2020 /
BiovalleyBIOON / -- Sanofi recently announced that the European Commission (EC) has approved the CD38 target antibody drug Sarclisa (isatuximab), combined with Pomadomide and Dexamethasone (pom-dex), used to treat adult patients who had previously received at least 2 treatments (including Naramine and a protease inhibitor) and showed progress during the last treatment, and in adult patients with refractive and incurable multiple myeloma (RRMM)Sarclisa is a monoclonal antibody (mAb) that binds to a specific epitope on a CD38 receptor of multiple myeloma (MM) cellsdata from the first randomized Phase III trial (ICARIA-MM) showed that sarclisa combined pom-dex treatment significantly reduced the risk of progression or death by 40 percent comparedcompared to pom-dex therapyin the United States, Sarclisa was approved in early March this year for combined pom-dex for RRMM adult patients who have received at least two treatments in the past, including naramine and protease inhibitorsIn addition, the Sarclisa joint pom-dex treatment program has been approved by Switzerland, Canada and Australiamultiple myeloma (MM) is the second most common blood cancer, with more than 138,000 newcases diagnosed worldwide each yearIn Europe, about 40,000 new cases are confirmed each year; Despite the treatmentavailable, MM is still an incurable malignanttumorassociated with a serious burden on the patientSince MM cannot be cured, most patients eventually relapse and no treatment is availableThe Sarclisa combined pomamine and dexamethasone (pom-dex) program will provide these patients with an important new treatment optionDr John Reed, head of global research and development at sanofi , said: "The European Commission's approval of Sarclisa represents an important additional treatment option that could lead to a new standard of care for patients with recurrent and refractory myeloma who require new effective treatments Clinical data show that In patients who had received at least two treatments failed, Sarclisa combined pom-dex therapy extended the progressionless survival by five months compared to the pom-dex treatment "
this approval is based on data from the critical Phase III ICARIA-MM study This is a randomized, open-label, multi-center study conducted in 96 centres in 24 countries and enrolled in a group of 307 PATIENTs with RRMM who have previously received a variety of (median 3) antimyeloma therapy, including at least 2 consecutive cycles of leamine and protease inhibitors alone or in combination In the study, isatuximab was administered intravenously at a dose of 10 mg/kg, once a week for 4 weeks, followed by a drug every other week, and used in combination with a standard dose of pom-dex during treatment this study is the first Phase III study to assess positive results from the Sarclisa Joint Standard Care (Pomadomine-Dasemeson, pom-dex) program, which involved patients with particularly difficult to treat and poor prognosis for relapse and refractory multiple myeloma, reflecting real-world clinical practice results showed that in such patients, Sarclisa and pom-dex combined treatment significantly extended the progression less than standard care (Pomadoamine-disephamin, pom-dex), and disease progression The risk of death was significantly reduced by 40% (HR: 0.596; 95% CI: 0.44-0.81; p-0.001), and significantly increased overall mitigation (ORR:60.4% vs 35.3%, p 0.0001) in addition, in addition, in addition, in addition, sarclisa and pom-dex combination therapy showed consistent therapeutic benefits in specific subgroups that reflectreal-world practices, including high-risk cell genetic patients, patients aged 75, patients with renal insufficiency, and patients with incurable amine In terms of safety, the most common adverse reactions of Sarclisa (in 20% or more patients) were neutropebutyl reduction (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 adverse adverse reactions were pneumonia (9.9%) and a decrease in febrile neutrophils (6.6%) "As patients experience a recurrence of multiple myeloma or become difficult to treat with current treatments, they become more difficult to treat and their prognosis is getting worse," said Dr Philippe Moreau, M.D., department of hematology at the University Hospital of Nantes, France, In the ICARIA-MM trial, Sarclisa combination therapy showed consistent therapeutic results in the recurring and refractive multiple myeloma subgroups Sarclisa provides an important new treatment regimen and potential new standards of care for patients with these recurrent, refractory diseases "
Sarclisa's active pharmaceutical ingredient is an IgG1 chimeric monoclonal antibody that targets specific epitopes of plasma cell CD38 receptors and can trigger a variety of unique mechanisms of action, including the promotion of programogenetic cell death (apoptosis) and immunomodulatory activity CD38 is expressed at a high level on multiple myeloma (MM) cells and is a target for cell surface receptors for antibody therapy in MM and other malignant tumors In both the United States and the European Union, isatuximab has been granted the right to treat Orphan SIn Sanofi is also evaluating the potential of isatuximab to treat malignant tumors in other blood systems
and solid tumors Sarclisa will be the first direct competitor to Johnson and Johnson's blockbuster CD38 target drug Darzalex, which went on sale in 2015 and posted global sales of $2.998 billion in 2019, up 48.0 percent from the previous year Analysts at Jefferies, a Wall Street investment bank, expect Sarclisa's annual sales to peak at more than $1bn Sanofi is currently promoting a number of Phase III clinical studies to evaluate the isatuximab combination of standard therapies currently available for the treatment of RRMM patients or MM patients with newly diagnostic (biovalleybioon.com) original origin: Sanofi European Commission app
roves Sarclisa® (isatuximab) for adults with relapsed and refractory multiple myeloma