EC approves new Sarclisa indication
The European Commission has approved Sanofi’s Sarclisa in combination with standard of care regimen carfilzomib and dexamethasone (Kd) for the treatment of relapsed multiple myeloma.
In a statement, Sanofi said that this is the second EU approval for Sarclisa in combination with a standard of care regimen for the treatment of relapsed or refractory multiple myeloma in the less than 12 months.
The most recent EU approval is based on data from the Phase III IKEMA study which included 302 patients with relapsed MM across 16 countries.
In this study, the median progression-free survival for patients receiving the Sanofi plus Kd regimen had not been reached at the time of a pre-planned interim analysis.
For patients receiving Kd alone, the median PFS had been reached and was found to be 19.15 months.
The Sarclisa combination therapy also reduced the risk of disease progression or death by 47% versus standard of care Kd alone in these patients with multiple myeloma.
Read more: http://www.pharmatimes.com/news/ec_approves_new_sarclisa_indication_1367395
In a statement, Sanofi said that this is the second EU approval for Sarclisa in combination with a standard of care regimen for the treatment of relapsed or refractory multiple myeloma in the less than 12 months.
The most recent EU approval is based on data from the Phase III IKEMA study which included 302 patients with relapsed MM across 16 countries.
In this study, the median progression-free survival for patients receiving the Sanofi plus Kd regimen had not been reached at the time of a pre-planned interim analysis.
For patients receiving Kd alone, the median PFS had been reached and was found to be 19.15 months.
The Sarclisa combination therapy also reduced the risk of disease progression or death by 47% versus standard of care Kd alone in these patients with multiple myeloma.
Read more: http://www.pharmatimes.com/news/ec_approves_new_sarclisa_indication_1367395
