Tuesday, October 19, 2021

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.

“The EC approval of Sarclisa in combination with carfilzomib and dexamethasone means patients living with multiple myeloma in Europe can now receive Sarclisa in combination with two standard of care treatment regimens,” said Peter Adamson, global development head, oncology and paediatric innovation at Sanofi.

“The carfilzomib and dexamethasone combination represents an important standard of care in Europe. The Phase 3 IKEMA trial’s finding that the addition of Sarclisa to this regimen reduced the risk of progression or death by nearly half formed the basis for this important EC approval,” he added.

Approximately 39,000 patients are diagnosed with multiple myeloma in Europe each year. Despite treatment advancements, multiple myeloma is an incurable malignancy and is associated with significant patient burden, with most patients experiencing a relapse.



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