Shots:
- The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients with relapsed MM across 69 centers spanning 16 countries
- Results: mPFS (not reached vs 19.15 mos.) at the time of the pre-planned interim analysis, reduction in the risk of disease progression or death by 47%. The 2EPs includes ORR (86.6% vs 82.9%), CR (39.7% vs 27.6%), VGPR (72.6% vs 56.1%), and MRD-negative response (29.6% vs 13%), 30% of patients achieved undetectable levels of MM at 10-5 sensitivity
- Sarclisa is a mAb involves binding with a specific epitope on the CD38 receptor and marks the second EC approval + SOC in less than 12mos.
Click here to read full press release/ article | Ref: Globe Newswire | Image: Evaluate Pharma
The post Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma first appeared on PharmaShots.
