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Second indication of Sarclisa for relapsed multiple myeloma approved by EC

Second indication of Sarclisa for relapsed multiple myeloma approved by EC
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Peterc Adamson , France Department Of Hematology Philippe Moreau , University Hospital Of Nantes , Pediatric Innovation Global Development , European Commission , Drug Administration , France Department , Hematology Philippe Moreau , பல்கலைக்கழகம் மருத்துவமனை ஆஃப் ந்யாஂட்ஸ் , குழந்தை கண்டுபிடிப்பு உலகளாவிய வளர்ச்சி , ஐரோப்பிய தரகு , பிரான்ஸ் துறை ,

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

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple .
SanofiApril 19, 2021 GMT
European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
Approval based on Phase 3 IKEMA study demonstrating Sarclisa added to standard of care carfilzomib and dexamethasone reduced risk of disease progression or death by 47% in patients who had relapsed after one to three prior therapies
Sarclisa combination therapy was associated with undetectable levels of multiple myeloma (MM) in nearly 30% of patients with relapsed MM
Second EU approval in less than 12 months for Sarclisa in combination with a standard of care regimen for the treatment of relapsed or refractory MM ....

France General , United States , United Kingdom , South Korea , Eva Schaefer Jansen , Suzanne Greco , Arnaud Delepine , Felix Lauscher , Philippe Moreau , Europe Thephase , 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 Innovationatsanofi , Safety Profile , Nonproprietary Naming , Biological Products Guidance , Empowering Life , Private Securities Litigation Reform Act ,

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 ,