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European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
pharmiweb.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmiweb.com Daily Mail and Mail on Sunday newspapers.

France General , United States , United Kingdom , South Korea , Eva Schaefer Jansen , Suzanne Greco , Arnaud Delepine , Felix Lauscher , Philippe Moreau , Innovationat Sanofi , Fara Berkowitz , Peterc Adamson , Sally Bain , University Hospital Of Nantes , International Myeloma Foundation , European Commission , Drug Administration , Department Of Hematology , Global Development Head , University Hospital , Pediatric Innovationat , Europe The Phase , Safety Profile , Difficult To Treat Patients , Nonproprietary Naming , Biological Products Guidance ,

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma

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the risk of progression or death by nearly half formed the basis for this important EC approval.

Sarclisa Efficacy and Safety Profile in Difficult-to-Treat Patients
This approval is based on data from the Phase 3 IKEMA study, a randomized, multi-center, open label clinical trial that enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries. The primary endpoint of IKEMA was progression free survival (PFS). While median PFS, defined as time to disease progression or death, for Kd was 19.15 months, the median PFS for patients receiving Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination therapy; n=179) had not been reached at the time of the pre-planned interim analysis. Sarclisa combination therapy reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007) versus standard of care Kd alone in patients with MM. ....

France General , United States , United Kingdom , South Korea , Eva Schaefer Jansen , Suzanne Greco , Arnaud Delepine , Felix Lauscher , Philippe Moreau , Innovationat Sanofi , Fara Berkowitz , Peterc Adamson , Sally Bain , University Hospital Of Nantes , International Myeloma Foundation , European Commission , Drug Administration , Department Of Hematology , Global Development Head , University Hospital , Pediatric Innovationat , Europe The Phase , Safety Profile , Difficult To Treat Patients , Nonproprietary Naming , Biological Products Guidance ,

Sanofi: European Commission approves second indication of Sarclisa (isatuximab) for relapsed multiple myeloma

Sanofi: European Commission approves second indication of Sarclisa (isatuximab) for relapsed multiple myeloma
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

France General , United States , United Kingdom , South Korea , Eva Schaefer Jansen , Suzanne Greco , Arnaud Delepine , Felix Lauscher , Philippe Moreau , Innovationat Sanofi , Fara Berkowitz , Peterc Adamson , Sally Bain , University Hospital Of Nantes , International Myeloma Foundation , European Commission , Drug Administration , Department Of Hematology , Global Development Head , University Hospital , Pediatric Innovationat , Europe The Phase , Safety Profile , Difficult To Treat Patients , Nonproprietary Naming , Biological Products Guidance ,

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
globenewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from globenewswire.com Daily Mail and Mail on Sunday newspapers.

France General , United States , United Kingdom , South Korea , Eva Schaefer Jansen , Suzanne Greco , Arnaud Delepine , Felix Lauscher , Philippe Moreau , Innovationat Sanofi , Fara Berkowitz , Peterc Adamson , Sally Bain , University Hospital Of Nantes , International Myeloma Foundation , European Commission , Drug Administration , Department Of Hematology , Global Development Head , University Hospital , Pediatric Innovationat , Europe The Phase , Safety Profile , Difficult To Treat Patients , Nonproprietary Naming , Biological Products Guidance ,