Sanofi’s Sarclisa (isatuximab) Receives CHMP’s Positive Opinion for Relapsed and Refractory Multiple Myeloma

Shots:

• The EMA’s CHMP positive opinion is based on P-III ICARIA-MM study assessing Sarclisa + pom-dex vs pom-dex as monothx. in patients with r/r MM prior treated with two therapies including lenalidomide and a proteasome inhibitor and demonstrated disease progression on the last therapy
• The P-III ICARIA-MM study results: improvement in PFS (11.53 vs 6.47mos.); ORR (60.4% vs. 35.3%). In an additional analysis, the therapy showed benefits in patients with high-risk cytogenetics, those aged ≥75yrs. with renal insufficiency and who were refractory to lenalidomide
• Sarclisa is mAb targeting CD38 receptor on MM cells, act by inducing apoptosis & immunomodulatory activity and has received FDA’s approval on Mar 02, 2019. The EC will review the CHMP’s recommendation with its decision on MAA anticipated in the coming months

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Pinterest